Trial Outcomes & Findings for A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) (NCT NCT01585324)

NCT ID: NCT01585324

Last Updated: 2015-07-24

Results Overview

SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 24 weeks after the end of treatment (72 weeks)
• Results posted on: 2015-07-24

Participant Flow

This clinical trial was originally planned to be conducted in 4 clinical trial centers in the Czech Republic. However, due to failure in manufacturing of the drug Pegasys, 3 of the previously approved study centers withdrew from participation. Consequently, the sponsor decided to conduct the clinical trial in 1 of the 4 originally planned centers.

Participant milestones

Measure	Peginterferon Alpha-2a + Ribavirin Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (\<) 75 kilogram \[kg\]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)

Baseline characteristics by cohort

Measure	Peginterferon Alpha-2a + Ribavirin n=30 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
Age, Continuous	32.1 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after the end of treatment (72 weeks)

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=30 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment	83.3 percentage of participants Interval 65.28 to 94.36	—

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR	-23.0 grams per liter (g/L) Standard Deviation 14.768	-32.4 grams per liter (g/L) Standard Deviation 11.502

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Number of Participants With Decrease in Hemoglobin Up to 20 g/L	9 participants	0 participants
Number of Participants With Decrease in Hemoglobin 20-40 g/L	14 participants	3 participants
Number of Participants With Decrease in Hemoglobin >40 g/L	2 participants	2 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR	124.24 g/L Standard Deviation 10.080	126.60 g/L Standard Deviation 10.383

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR	1 participants	0 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Number of Participants With Neutropenia Among Participants With or Without SVR	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Measure	Peginterferon Alpha-2a + Ribavirin n=25 Participants Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.	Participants Without SVR n=5 Participants Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
Number of Participants With Thrombocytopenia Among Participants With or Without SVR	1 participants	0 participants

Adverse Events

Peginterferon Alpha-2a + Ribavirin

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Peginterferon Alpha-2a + Ribavirin n=30 participants at risk Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight \<75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
General disorders Fatigue	16.7% 5/30 • From baseline up to 24 weeks after end of treatment (up to 72 weeks)
General disorders Influenza like illness	46.7% 14/30 • From baseline up to 24 weeks after end of treatment (up to 72 weeks)

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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