A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritabprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis

Phase 1

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 19.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001477-13-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female at least 18 years of age at time of Screening.
2. HCV GT1 or GT4 infection defined as: Positive for anti-HCV Ab, HCV RNA >1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening.
3. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (ie CT or MRI).
4. Child-Pugh Score 7-9 inclusive at time of Screening.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) with positive Western blot.
3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegIFN/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir)
4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (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).
5. Any current or past evidence of Child-Pugh C classification

Study & Design

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