A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 Infection (Endurance-1)

Phase 1

• Conditions: HCV Genotype 1 and HCV Genotype 1/HIV-1 co-infected subjects; MedDRA version: 19.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002087-17-SE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-09
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

1. Male or female, at least 18 years of age at time of screening.
2. Screening laboratory result indicating HCV GT1 infection.
3. Chronic HCV infection.
4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy).
5. Subjects must be non-cirrhotic.

Additional Inclusion Criteria for GT1 HCV/HIV-1 co-infected patients:
6. HIV-1 ART naïve with CD4 = 500 cells/mm3 [or CD4+ % =29%] at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.
Or
On a stable, qualifying HIV-1 ART regimen (Section 5.2.3.2) for at least 8 weeks prior to screening, with CD4 = 200 cells/mm3 [or CD4+ % =14%] at Screening and plasma HIV-1 RNA 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 580
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
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).
5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
6. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified