A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
|ClinicalTrials.gov Identifier: NCT00922779|
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6661 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C|
|Study Start Date :||June 2002|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Drug: peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 12-48 weeksDrug: ribavirin
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
- Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) [ Time Frame: From signing of informed consent up to end of study (up to Week 72) ]An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.
- Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy [ Time Frame: 24 weeks after end of therapy (Week 72) ]SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.
- Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation [ Time Frame: Weeks 12,24 and 48 After Therapy Initiation ]HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.
- Percentage of Participants With Change in Hemoglobin Level [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) ]Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922779
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|Study Director:||Clinical Trials||Hoffmann-La Roche|