The trial was terminated due to change in new standard of therapy during the study period.

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.

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.

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

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.