Overview

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.