A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or without Dasabuvir and with Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults with Successfully Treated Early Stage Hepatocellular Carcinoma
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-001049-10-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3
Main Inclusion:
1. Male or female, at least 18 years of age at time of screening.
2. Chronic HCV infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection.
3. Early stage HCC diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening.
5. Documented complete response to HCC treatment.
6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Main Exclusion:
1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in subjects receiving OBV/PTV/r with and without DSV, strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in subjects receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-DAA and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
3. Patients not eligible for liver transplantation due to significant cardio vascular or pulmonary disease.
4. Clinically significant abnormalities, other than HCV infection, in a subject with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method