Status:
COMPLETED
Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
Lead Sponsor:
Beni-Suef University
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Detailed Description
Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, G...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04382339
Start Date
March 1 2015
End Date
November 1 2015
Last Update
May 11 2020
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