A Study to evaluate the Effect and Safety of experimental drugs ABT-493/ABT-530 in adults with Chronic Hepatitis C Virus Genotype 1-6 Infection and Renal Impairment
- Conditions
- Chronic HCV Genotype 1-6 InfectionMedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-002353-35-BE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Male or female at least 18 years of age at time of Screening.
2. Screening laboratory result indicating chronic HCV GT1-6 infection.
3. Subject must be HCV treatment-naïve or have received prior HCV treatment with IFN or pegIFN with or without RBV, pegIFN/RBV plus SOF, or SOF plus RBV.
4. Subject must have chronic renal impairment (CKD stage 4 or 5).
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The percentage of subjects with SVR 12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug);Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug;Main Objective: To assess the virologic response to 12 weeks of treatment with ABT-493/ABT-530 by determining the percentage of subjects who achieved a sustained virologic response at 12 weeks post-treatment (SVR12) and to evaluate safety of ABT-493/ABT-530 in adults with chronic HCV genotype 1 – 6 infection with chronic renal impairment.;Secondary Objective: ? The percentages of subjects with on-treatment virologic failure;<br>? The percentages of subjects with post-treatment relapse.<br>? To assess pharmacokinetics of ABT-493/ABT-530 and the emergence and persistence of viral variants in this treatment regimen.<br><br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: * Start of treatment (Day 1) until End of Treatment.<br><br>* 12 weeks after end of treatment;Secondary end point(s): * The percentage of subjects with on treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA = 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA = LLOQ at the end of treatment with at least 6 weeks of treatment);<br><br>* The percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequencing).