Status:
COMPLETED
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Virus (HCV) Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-in...
Detailed Description
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lowe...
Eligibility Criteria
Inclusion
- Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
Exclusion
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- Evidence of current or past Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma
- Abnormal laboratory tests
- Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
- Previous treatment with a direct acting antiviral agent (DAA) containing regimen
- History of solid organ transplant.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02216422
Start Date
September 1 2014
End Date
December 1 2015
Last Update
June 29 2016
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