Trial Outcomes & Findings for Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390 (NCT NCT00996216)

Last Updated: 2013-12-06

Results Overview

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

27 participants

Primary outcome timeframe

From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Results posted on

2013-12-06

Participant Flow

10\^9 cells (Giga) per liter=Gi/L; participants=par.; polyethylene glycol=Peg; interferon=INF.

In Part (P) 1, the treatment goal was to increase the platelet count to \>=90 Gi/L. In P 2, par. continued on the selected P 1 dose of eltrombopag (dose effectively raising platelets to \>=90 or \>=100 Gi/L). Eltrombopag was given in combination with antiviral therapy (Peg INF alfa-2a or Peg INF alfa-2b and ribavirin) for the duration of treatment.

Participant milestones

Participant milestones
Measure	Eltrombopag In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Part 1 (Pre-Antiviral Treatment Phase) STARTED	27
Part 1 (Pre-Antiviral Treatment Phase) COMPLETED	26
Part 1 (Pre-Antiviral Treatment Phase) NOT COMPLETED	1
Part 2 (Antiviral Treatment Phase) STARTED	25
Part 2 (Antiviral Treatment Phase) COMPLETED	21
Part 2 (Antiviral Treatment Phase) NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Eltrombopag In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Part 1 (Pre-Antiviral Treatment Phase) Withdrawal by Subject	1
Part 2 (Antiviral Treatment Phase) Lost to Follow-up	3
Part 2 (Antiviral Treatment Phase) Withdrawal by Subject	1

Baseline Characteristics

Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Age Continuous	51.3 Years STANDARD_DEVIATION 7.70 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Central/South Asian Heritage	2 participants n=5 Participants
Race/Ethnicity, Customized White	25 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Population: Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 Any SAE	0 Participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 Any AE	9 Participants

PRIMARY outcome

Timeframe: From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)

Population: Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy

Outcome measures

Outcome measures
Measure	Eltrombopag n=25 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With Any AE and Any SAE in Part 2 Any SAE	5 Participants
Number of Participants With Any AE and Any SAE in Part 2 Any AE	25 Participants

PRIMARY outcome

Timeframe: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Population: Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Outcome measures

Outcome measures
Measure	Eltrombopag n=26 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alanine amino transferase, Any Increase	2 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alanine amino transferase, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alanine amino transferase, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alanine amino transferase, Increase to Grade 3	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alanine amino transferase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Albumin, Any Increase	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Albumin, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Albumin, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Albumin, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Albumin, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alkaline phosphatase, Any Increase	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alkaline phosphatase, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alkaline phosphatase, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alkaline phosphatase, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Alkaline phosphatase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Aspartate amino transferase, Any Increase	2 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Aspartate amino transferase, Increase to Grade 1	2 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Aspartate amino transferase, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Aspartate amino transferase, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Aspartate amino transferase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Creatinine, Any Increase	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Creatinine, Increase to Grade 1	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Creatinine, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Creatinine, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Creatinine, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Total bilirubin, Any Increase	10 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Total bilirubin, Increase to Grade 1	6 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Total bilirubin, Increase to Grade 2	4 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Total bilirubin, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Total bilirubin, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Uric acid, Any Increase	3 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Uric acid, Increase to Grade 1	3 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Uric acid, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Uric acid, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 Uric acid, Increase to Grade 4	0 Participants

PRIMARY outcome

Timeframe: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Population: Antiviral Safety Population

Outcome measures

Outcome measures
Measure	Eltrombopag n=25 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Creatinine, Increase to Grade 3	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Total bilirubin, Increase to Grade 2	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alanine amino transferase, Any Increase	4 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alanine amino transferase, Increase to Grade 1	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alanine amino transferase, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alanine amino transferase, Increase to Grade 3	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alanine amino transferase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Albumin, Any Increase	9 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Albumin, Increase to Grade 1	4 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Albumin, Increase to Grade 2	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Albumin, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Albumin, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alkaline phosphatase, Any Increase	7 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alkaline phosphatase, Increase to Grade 1	7 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alkaline phosphatase, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alkaline phosphatase, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Alkaline phosphatase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Aspartate amino transferase, Any Increase	9 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Aspartate amino transferase, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Aspartate amino transferase, Increase to Grade 2	8 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Aspartate amino transferase, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Aspartate amino transferase, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Creatinine, Any Increase	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Creatinine, Increase to Grade 1	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Creatinine, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Creatinine, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Total bilirubin, Any Increase	16 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Total bilirubin, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Total bilirubin, Increase to Grade 3	10 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Total bilirubin, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Uric acid, Any Increase	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Uric acid, Increase to Grade 1	4 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Uric acid, Increase to Grade 2	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Uric acid, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 Uric acid, Increase to Grade 4	0 Participants

PRIMARY outcome

Timeframe: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Population: Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.

Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Outcome measures

Outcome measures
Measure	Eltrombopag n=26 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Hemoglobin, Any Increase	2 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Hemoglobin, Increase to Grade 1	2 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Hemoglobin, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Hemoglobin, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Hemoglobin, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Lymphocytes, Any Increase	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Lymphocytes, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Lymphocytes, Increase to Grade 2	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Lymphocytes, Increase to Grade 3	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Lymphocytes, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Total neutrophils, Any Increase	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Total neutrophils, Increase to Grade 1	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Total neutrophils, Increase to Grade 2	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Total neutrophils, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 Total neutrophils, Increase to Grade 4	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 White Blood cell count, Any Increase	2 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 White Blood cell count, Increase to Grade 1	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 White Blood cell count, Increase to Grade 2	2 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 White Blood cell count, Increase to Grade 3	0 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 White Blood cell count, Increase to Grade 4	0 Participants

PRIMARY outcome

Timeframe: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Population: Antiviral Safety Population

Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.

Outcome measures

Outcome measures
Measure	Eltrombopag n=25 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Lymphocytes, Increase to Grade 3	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Total neutrophils, Increase to Grade 4	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Hemoglobin, Any Increase	12 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Hemoglobin, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Hemoglobin, Increase to Grade 2	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Hemoglobin, Increase to Grade 3	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Hemoglobin, Increase to Grade 4	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Lymphocytes, Any Increase	15 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Lymphocytes, Increase to Grade 1	1 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Lymphocytes, Increase to Grade 2	3 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Lymphocytes, Increase to Grade 4	8 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Total neutrophils, Any Increase	23 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Total neutrophils, Increase to Grade 1	4 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Total neutrophils, Increase to Grade 2	10 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 Total neutrophils, Increase to Grade 3	8 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 White Blood Cell count, Any Increase	20 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 White Blood Cell count, Increase to Grade 1	5 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 White Blood Cell count, Increase to Grade 2	7 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 White Blood Cell count, Increase to Grade 3	7 Participants
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 White Blood Cell count, Increase to Grade 4	1 Participants

PRIMARY outcome

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Population: Entire Safety Population: all participants in the Pre-antiviral Safety Population

Visual acuity (VA) is defined as acuteness or clearness of vision.

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 Decrease in Visual Acuity, Yes	10 Participants
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 Decrease in Visual Acuity, No	15 Participants
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 Decrease in Visual Acuity, Missing or Unknown	2 Participants

PRIMARY outcome

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Population: Entire Safety Population

LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 logMAR Changes, >=0.20 to <0.30 (Loss of 2 Lines)	3 Participants
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 logMAR Changes, <0.10 (No Change or Improvement)	15 Participants
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 logMAR Changes, >=0.10 to <0.20 (Loss of 1 Line)	6 Participants
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 logMAR Changes, >=0.30 (Loss of 3 Lines or more)	1 Participants
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 logMAR Changes, Missing or Unknown	2 Participants

PRIMARY outcome

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Population: Entire Safety Population

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 logMAR change, Yes	4 Participants
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 logMAR change, No	21 Participants
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 logMAR change, Missing or Unknown	2 Participants

SECONDARY outcome

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Population: Pre-antiviral Safety Population

Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Platelet Counts at the Indicated Time Points Screening, n=27	53.1 Gi/L Standard Deviation 12.90
Platelet Counts at the Indicated Time Points Part 1/Day 1, n=27	55.9 Gi/L Standard Deviation 18.69
Platelet Counts at the Indicated Time Points Part 1/Week 1, n=25	73.3 Gi/L Standard Deviation 29.27
Platelet Counts at the Indicated Time Points Part 1/Week 2, n=16	83.2 Gi/L Standard Deviation 27.90
Platelet Counts at the Indicated Time Points Part 1/Week 3, n=8	73.4 Gi/L Standard Deviation 26.53
Platelet Counts at the Indicated Time Points Part 1/Week 4, n=7	75.6 Gi/L Standard Deviation 19.95
Platelet Counts at the Indicated Time Points Part 1/Week 5, n=5	72.2 Gi/L Standard Deviation 18.29
Platelet Counts at the Indicated Time Points Part 1/Week 6, n=5	81.6 Gi/L Standard Deviation 14.45
Platelet Counts at the Indicated Time Points Part 1/Week 7, n=5	76.2 Gi/L Standard Deviation 19.88
Platelet Counts at the Indicated Time Points Part 1/Week 8, n=3	91.7 Gi/L Standard Deviation 22.81
Platelet Counts at the Indicated Time Points Part 2/Antiviral Baseline, n=25	132.9 Gi/L Standard Deviation 33.72
Platelet Counts at the Indicated Time Points Part 2/Week 1, n=25	106.7 Gi/L Standard Deviation 37.80
Platelet Counts at the Indicated Time Points Part 2/Week 2, n=25	93.2 Gi/L Standard Deviation 42.98
Platelet Counts at the Indicated Time Points Part 2/Week 4, n=23	80.5 Gi/L Standard Deviation 30.64
Platelet Counts at the Indicated Time Points Part 2/Week 8, n=21	80.3 Gi/L Standard Deviation 24.40
Platelet Counts at the Indicated Time Points Part 2/Week 12, n=20	83.1 Gi/L Standard Deviation 31.72
Platelet Counts at the Indicated Time Points Part 2/Week 16, n=16	85.8 Gi/L Standard Deviation 27.61
Platelet Counts at the Indicated Time Points Part 2/Week 20, n=14	75.3 Gi/L Standard Deviation 22.54
Platelet Counts at the Indicated Time Points Part 2/Week 24, n=11	78.6 Gi/L Standard Deviation 30.63
Platelet Counts at the Indicated Time Points Part 2/Week 28, n=9	90.3 Gi/L Standard Deviation 50.09
Platelet Counts at the Indicated Time Points Part 2/Week 32, n=7	86.1 Gi/L Standard Deviation 72.12
Platelet Counts at the Indicated Time Points Part 2/Week 36, n=6	76.8 Gi/L Standard Deviation 53.77
Platelet Counts at the Indicated Time Points Part 2/Week 40, n=5	55.8 Gi/L Standard Deviation 27.65
Platelet Counts at the Indicated Time Points Part 2/Week 44, n=5	54.4 Gi/L Standard Deviation 29.18
Platelet Counts at the Indicated Time Points Part 2/Week 48, n=2	68.0 Gi/L Standard Deviation 29.70
Platelet Counts at the Indicated Time Points Part 2/Week 52, n=1	49.0 Gi/L Standard Deviation NA A standard deviation cannot be calculated when mean data are available for only one participant.
Platelet Counts at the Indicated Time Points Part 2/Week 56, n=1	47.0 Gi/L Standard Deviation NA A standard deviation cannot be calculated when mean data are available for only one participant.
Platelet Counts at the Indicated Time Points Part 2/Week 60, n=1	43.0 Gi/L Standard Deviation NA A standard deviation cannot be calculated when mean data are available for only one participant.
Platelet Counts at the Indicated Time Points Part 2/Week 64, n=1	43.0 Gi/L Standard Deviation NA A standard deviation cannot be calculated when mean data are available for only one participant.
Platelet Counts at the Indicated Time Points Part 2/Week 68, n=1	44.0 Gi/L Standard Deviation NA A standard deviation cannot be calculated when mean data are available for only one participant.
Platelet Counts at the Indicated Time Points Post-treatment/4 Week Follow-up, n=23	77.8 Gi/L Standard Deviation 33.48
Platelet Counts at the Indicated Time Points Post-treatment/24 Week Follow-up, n=22	52.5 Gi/L Standard Deviation 17.91
Platelet Counts at the Indicated Time Points Investigational product discontinuation, n=26	91.3 Gi/L Standard Deviation 38.78
Platelet Counts at the Indicated Time Points Maximum value post-Baseline, n=26	145.5 Gi/L Standard Deviation 43.68

SECONDARY outcome

Timeframe: From the start of the investigational product up to 9 weeks (median of 21 days)

Population: Pre-antiviral Safety Population

The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.

Outcome measures

Outcome measures
Measure	Eltrombopag n=27 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Particpants Who Initiated Antiviral Therapy Yes	25 Participants
Number of Particpants Who Initiated Antiviral Therapy No	2 Participants

SECONDARY outcome

Timeframe: From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Population: Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.

SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.

Outcome measures

Outcome measures
Measure	Eltrombopag n=25 Participants In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) RVR, Yes, n=12	3 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) ETR, No, n=21	12 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) SVR, Yes, n=17	4 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) SVR, No, n=17	13 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) RVR, No, n=12	9 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) EVR, Yes, n=15	15 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) EVR, No, n=15	0 Participants
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) ETR, Yes, n=21	9 Participants

Adverse Events

Eltrombopag (Part 1)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Eltrombopag (Part 2)

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eltrombopag (Part 1) n=27 participants at risk In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.	Eltrombopag (Part 2) n=25 participants at risk Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
Nervous system disorders Hepatic encephalopathy	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Nervous system disorders Myoclonic epilepsy	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Infections and infestations Cellulitis	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/27 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).	4.0% 1/25 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of the 24-week follow up period (up to Week 96/WD).

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER