A Phase 3 interventional study of Ribavirin and peginterferon alfa-2a in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Terminated at 21 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-08.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 23 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
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Participants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day \[mg/day\] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks.
Drug: Ribavirin · Drug: peginterferon alfa-2a
Also known as: Copegus, Ro 20-9963
Also known as: Pegasys, Ro 25-8310
Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 12
Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 56
Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 32
Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load
Time frame: Baseline, Week 2, 4, 8, 12, 32, 56
Number of Participants With Adverse Events and Serious Adverse
Time frame: Baseline up to Week 56
The record gives a start of Jun 2005, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ribavirin · Peginterferon alfa-2a