Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C
Decompensated Cirrhosis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
Eligibility Criteria
Inclusion
- HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA \> 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.
- Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]).
- Child-Pugh Score of 7 - 9, inclusive, at time of Screening.
Exclusion
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
- Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).
- Any current or past evidence of Child-Pugh C classification.
Key Trial Info
Start Date :
November 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02219477
Start Date
November 24 2014
End Date
March 3 2017
Last Update
July 11 2017
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