Trial Outcomes & Findings for POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin). (NCT NCT00700401)
NCT ID: NCT00700401
Last Updated: 2016-06-21
Results Overview
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Recruitment status
COMPLETED
Target enrollment
262 participants
Primary outcome timeframe
At Week 48
Results posted on
2016-06-21
Participant Flow
A total of 262 participants were enrolled from 13 centers in Brazil. This study was conducted between 26 November 2008 and 19 November 2010.
Participant milestones
| Measure |
Peginterferon Alfa-2a + Ribavirin
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Overall Study
STARTED
|
262
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
94
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a + Ribavirin
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Overall Study
Detectable HCV RNA after Week 4
|
82
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Refused Treatment
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Treatment never started
|
1
|
|
Overall Study
HCV RNA not detected at baseline and SAE
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Age, Continuous
|
49.7 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 48Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Percentage of Participants With Sustained Virological Response at Week 48
|
52.7 Percentage of participants
Interval 46.6 to 58.6
|
SECONDARY outcome
Timeframe: At Week 4Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Percentage of Participants With Rapid Virological Response at Week 4
|
56.9 Percentage of participants
Interval 50.8 to 62.7
|
SECONDARY outcome
Timeframe: At Week 24Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Percentage of Participants With Virological Response at Week 24
|
56.9 Percentage of participants
Interval 50.8 to 62.7
|
SECONDARY outcome
Timeframe: At week 48Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=149 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Percentage of Participants With Virological Relapse
|
9.4 Percentage of participants
Interval 5.7 to 15.2
|
SECONDARY outcome
Timeframe: At Week 48Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.
Positive predictive value is defined as participants with RVR who did not achieve SVR.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=149 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Percentage of Participants With Positive Predictive Value
|
85.2 percentage of participants
Interval 78.7 to 90.0
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
An any adverse events (AEs) 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 to be related to the medicinal product. An serious adverse events (SAEs) is 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, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
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|---|---|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Any AEs
|
196 participants
|
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Any SAEs
|
13 participants
|
SECONDARY outcome
Timeframe: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=259 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Platelets, Week 2 ( n = 257)
|
-18.3 Percent change
Standard Error 1.7
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Platelets, Week 4 (n = 259)
|
-20.4 Percent change
Standard Error 1.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hemoglobin, Week 2 ( n =257)
|
-8.4 Percent change
Standard Error 0.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hemoglobin, Week 4 (n=259)
|
-15.7 Percent change
Standard Error 0.6
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hemoglobin, Week 12 (n=157)
|
-19.6 Percent change
Standard Error 0.7
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hemoglobin, Week 24 (n=156)
|
-20.7 Percent change
Standard Error 0.8
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hemoglobin, Week 48 (n=110)
|
-2.2 Percent change
Standard Error 0.6
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematocrit, Week 2 ( n = 255)
|
-8.1 Percent change
Standard Error 0.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematocrit, Week 4 (n = 257)
|
-14.5 Percent change
Standard Error 0.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematocrit, Week 12 (n = 156)
|
-17.7 Percent change
Standard Error 0.7
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematocrit, Week 24 (n = 155)
|
-17.9 Percent change
Standard Error 0.8
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematocrit, Week 48 (n=110)
|
-2.3 Percent change
Standard Error 0.6
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Leukocytes, Week 2 ( n = 256)
|
-33.2 Percent change
Standard Error 1.2
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Leukocytes, Week 4 (n = 258)
|
-43.4 Percent change
Standard Error 1
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Leukocytes, Week 12 (n = 157)
|
-48.1 Percent change
Standard Error 2.1
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Leukocytes, Week 24 (n = 156)
|
-52.1 Percent change
Standard Error 1.4
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Leukocytes, Week 48 (n = 110)
|
0.3 Percent change
Standard Error 2.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Neutrophils, Week 2 ( n = 256)
|
-42.9 Percent change
Standard Error 2.4
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Neutrophils, Week 4 (n = 258)
|
-48 Percent change
Standard Error 2.5
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Neutrophils, Week 12 (n = 157)
|
-47.3 Percent change
Standard Error 4.1
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Neutrophils, Week 24 (n = 156)
|
-53.6 Percent change
Standard Error 2
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Neutrophils, Week 48 (n = 110)
|
4.5 Percent change
Standard Error 3.7
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Platelets, Week 12 (n = 157)
|
-26.7 Percent change
Standard Error 2.4
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Platelets, Week 24 (n = 155)
|
-27.6 Percent change
Standard Error 1.9
|
|
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Platelets, Week 48 (n = 110)
|
4 Percent change
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24 and Week 48Population: Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of \>3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
Outcome measures
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=257 Participants
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
ALT, Week 4 ( n = 257)
|
-28.5 Percent change
Standard Error 4.8
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
ALT, Week 12 (n = 159)
|
-30.4 Percent change
Standard Error 5.5
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
ALT, Week 24 (n = 156)
|
-30 Percent change
Standard Error 8.6
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
ALT, Week 48 (n = 125)
|
-61.8 Percent change
Standard Error 3.1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
AST, Week 4 ( n = 256)
|
-19.6 Percent change
Standard Error 2.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
AST, Week 12 (n = 159)
|
-10.2 Percent change
Standard Error 4.9
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
AST, Week 24 (n = 156)
|
-7.6 Percent change
Standard Error 8.4
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
AST, Week 48 (n = 125)
|
-47.2 Percent change
Standard Error 2.9
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Gamma-GT, Week 4 ( n = 243)
|
11.8 Percent change
Standard Error 3.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Gamma-GT, Week 12 (n = 151)
|
32.5 Percent change
Standard Error 7.9
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Gamma-GT, Week 24 (n = 149)
|
69.2 Percent change
Standard Error 25.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Gamma-GT, Week 48 (n = 121)
|
-33.4 Percent change
Standard Error 3.5
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting cholesterol, Week 4 ( n = 214)
|
-1 Percent change
Standard Error 1.6
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting cholesterol, Week 12 (n = 130)
|
-1.4 Percent change
Standard Error 2.4
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting cholesterol, Week 24 (n = 123)
|
0.6 Percent change
Standard Error 2.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting cholesterol, Week 48 (n = 97)
|
15.6 Percent change
Standard Error 2.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting blood glucose, Week 4 ( n = 229)
|
-3.5 Percent change
Standard Error 1.1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting blood glucose, Week 12 (n = 135)
|
-1.8 Percent change
Standard Error 2.5
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting blood glucose, Week 24 (n = 136)
|
1.3 Percent change
Standard Error 2.4
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting blood glucose, Week 48 (n = 111)
|
-1.2 Percent change
Standard Error 2.1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting insulin, Week 4 ( n = 131)
|
22.9 Percent change
Standard Error 11.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting insulin, Week 12 (n = 79)
|
11.1 Percent change
Standard Error 11.6
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting insulin, Week 24 (n = 74)
|
-12.2 Percent change
Standard Error 5.8
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting insulin, Week 48 (n = 68)
|
18.3 Percent change
Standard Error 16.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Total bilirubin, Week 4 ( n = 234)
|
32.8 Percent change
Standard Error 4.4
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Total bilirubin, Week 12 (n = 148)
|
19.3 Percent change
Standard Error 5.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Total bilirubin, Week 24 (n = 123)
|
0 Percent change
Standard Error 3.9
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Total bilirubin, Week 48 (n = 108)
|
-1.7 Percent change
Standard Error 4.5
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Creatinine, Week 4 ( n = 239)
|
-1.82 Percent change
Standard Error 0.99
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Creatinine, Week 12 (n = 138)
|
-2.71 Percent change
Standard Error 1.43
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Creatinine, Week 24 (n = 133)
|
-3.55 Percent change
Standard Error 1.55
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Creatinine, Week 48 (n = 116)
|
5.89 Percent change
Standard Error 1.78
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting triglycerides, Week 4 ( n = 212)
|
44.7 Percent change
Standard Error 4.8
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting triglycerides, Week 12 (n = 128)
|
56 Percent change
Standard Error 7.2
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting triglycerides, Week 24 (n = 121)
|
58.1 Percent change
Standard Error 7.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Fasting triglycerides, Week 48 (n = 92)
|
22 Percent change
Standard Error 6.5
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
HOMA score, Week 4 ( n = 46)
|
12.6 Percent change
Standard Error 23.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
HOMA score, Week 12 (n = 37)
|
10.3 Percent change
Standard Error 20.6
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
HOMA score, Week 24 (n = 28)
|
-14.6 Percent change
Standard Error 11.6
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
HOMA score, Week 48 (n = 20)
|
10.9 Percent change
Standard Error 19.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
PT, Week 4 ( n = 55)
|
-1.9 Percent change
Standard Error 0.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
PT, Week 12 (n = 31)
|
-2.6 Percent change
Standard Error 1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
PT, Week 24 (n = 26)
|
-3.5 Percent change
Standard Error 1.7
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
PT, Week 48 (n = 30)
|
-4.1 Percent change
Standard Error 1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
INR, Week 4 ( n = 151)
|
0.1 Percent change
Standard Error 1.3
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
INR, Week 12 (n = 73)
|
-1.1 Percent change
Standard Error 0.8
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
INR, Week 24 (n = 73)
|
-1.5 Percent change
Standard Error 1.1
|
|
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
INR, Week 48 (n = 71)
|
-3.2 Percent change
Standard Error 0.8
|
Adverse Events
Peginterferon Alfa-2a + Ribavirin
Serious events: 13 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 participants at risk
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
3/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anorectal operation
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.38%
1/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Peginterferon Alfa-2a + Ribavirin
n=262 participants at risk
Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg \[\<75kg\] or 1200 mg \[\>/=75 kg\]) for 24 weeks were observed.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
27/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
18/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
27/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
19.5%
51/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
16.0%
42/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
12.2%
32/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
8.8%
23/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Irritability
|
7.6%
20/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
6.1%
16/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
42/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.0%
42/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
17/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
26.3%
69/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Insomnia
|
7.3%
19/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
6.5%
17/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
14/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
30/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
15/262 • Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER