Status:
COMPLETED
Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients
Lead Sponsor:
Beni-Suef University
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
Detailed Description
Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally bas...
Eligibility Criteria
Inclusion
- The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
- The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 \> 3.25 (advanced fibrosis or cirrhosis), albumin \< 3.5, total bilirubin \> 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.
Exclusion
- liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
- poorly controlled diabetes (HbA1C \> 8)
- participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
- renal failure
- evidence of hepatic decompensation
- blood picture abnormalities such as anemia (hemoglobin concentration of \< 10 g/dL)
- thrombocytopenia (platelets count \< 50,000 cells/mm3).
- major severe illness such as congestive heart failure and respiratory failure.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04391985
Start Date
March 1 2017
End Date
October 31 2017
Last Update
May 18 2020
Active Locations (1)
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1
Beni-Suef University
Banī Suwayf, Egypt