Status:
COMPLETED
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
Lead Sponsor:
Beni-Suef University
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Detailed Description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was ...
Eligibility Criteria
Inclusion
- Non-cirrhotic treatment-naïve participants
- FIB-4 \< 3.25
- albumin \> 3.5
- total bilirubin \< 1.2 mg/dl
- international normalized ratio (INR) \< 1.2
- platelet count \> 150,000 mm3.
- experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
- Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis
Exclusion
- liver disease of non-HCV etiology
- hepatitis B or human immune-deficiency virus (HIV) infection
- poorly controlled diabetic (HbA1C \> 9) participants
- hepatocellular carcinoma
- a history of extra-hepatic malignancy within 5 years prior to the study
- pregnant or breast feeding
- renal disease; serum creatinine \> 2.5 mg/dl or eGFR \< 30 ml/min
- evidence of hepatic decompensation; INR \> 1.7, serum albumin \< 2.8 g/dl, total bilirubin \> 3 mg/dl
- blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count \< 50,000 cells/mm3)
- major severe illnesses such as congestive heart failure and respiratory failure.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
946 Patients enrolled
Trial Details
Trial ID
NCT04387526
Start Date
April 1 2016
End Date
May 31 2017
Last Update
May 15 2020
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