Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University

Criteria

Inclusion Criteria:

The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.

Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

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Exclusion Criteria:Participants with one or more of

• HCV coinfected with hepatitis B virus (HBV)

• human immunodeficiency virus (HIV)

• had any liver disease other than chronic HCV GT4 infection.

• had a history of liver decompensation

• serum a-fetoprotein (AFP) > 100 ng/ml

• evidence of hepatocellular carcinoma

• major severe illness such as respiratory, renal, heart failure or autoimmune disease

• non-compliance with treatment.