Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 45
- Primary Endpoint
- Number of Participants Achieving Sustained Virologic Response (SVR)
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
Detailed Description
Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is ≥40 kg and ≤120 kg weight
- •Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
- •Previously documented CHC genotype 4 infection
- •Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).
Exclusion Criteria
- •Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
- •Treatment for hepatitis C with any investigational medication
- •Treatment with any investigational drug within 30 days of the screening visit
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •Autoimmune hepatitis or a history of autoimmune disease
- •Hepatic fibrosis score F4
- •Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
- •Autoimmune hepatitis or a history of autoimmune disease
- •Thyroid disease uncontrolled with conventional treatment
- •Epilepsy and/or compromised central nervous system (CNS) function
Arms & Interventions
44 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: ribavirin (Drug)
44 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: PEG-IFN alfa-2b (Drug)
20 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: PEG-IFN alfa-2b (Drug)
20 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: ribavirin (Drug)
Outcomes
Primary Outcomes
Number of Participants Achieving Sustained Virologic Response (SVR)
Time Frame: At 24 weeks after the completion of therapy (up to 72 weeks)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Secondary Outcomes
No secondary outcomes reported