Status:
COMPLETED
Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
Lead Sponsor:
Beni-Suef University
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
Detailed Description
Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and families have been revolutionized the management landscape of chronic hepatitis C virus (HCV). Ombitasvir, p...
Eligibility Criteria
Inclusion
- Treatment-naïve patients with HCV GT4 with plasma HCV RNA level \>10,000 IU/ml
Exclusion
- Hepatitis of non-HCV cause
- Coinfection with other than HCV GT4
- Poorly controlled diabetics (HbA1C \>8) patients
- a history of extra-hepatocellular malignancy in the last 5 years
- Major severe illness such as congestive heart failure, respiratory failure, evidence of hepatic decompensation.
- Laboratory and blood picture abnormalities such as anemia (hemoglobin concentration of 10 \<g/dl) and thrombocytopenia (platelets \<50,000 cells/mm3) and (serum albumin \<2.8 g/dL, international normalized ratio (INR) of \> 2.3, serum total bilirubin concentration of \>3.0 mg/dL.
Key Trial Info
Start Date :
January 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04378608
Start Date
January 5 2017
End Date
September 8 2017
Last Update
May 12 2020
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