Status:
COMPLETED
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
Lead Sponsor:
Beni-Suef University
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Detailed Description
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enr...
Eligibility Criteria
Inclusion
- Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments \[SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV\]
- Fibrosis-4 score in non-cirrhotic participants is \<1.45-3.25: (None or moderate fibrosis)
- Fibrosis-4 score in cirrhotic participants is \>3.25: (Advanced fibrosis or cirrhosis)
Exclusion
- HCV coinfected with hepatitis B virus (HBV) or 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 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04387539
Start Date
March 1 2017
End Date
October 31 2017
Last Update
May 14 2020
Active Locations (1)
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1
Health Administration at Beni-Seuf
Bani Sweif, Egypt