An Exploratory Study to Evaluate the Kinetics of Viral Load Decline with Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy with Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infectio

Phase 1

• Conditions: Chronic Hepatitis C Virus (HCV) Infection; MedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001478-32-FR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-23
• Last Update Posted: 23 January 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. Screening laboratory result indicating HCV GT1a infection.
3. Chronic HCV infection.
4. Subjects must be non-cirrhotic.
5. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an IRB/EC approved informed consent.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
3. Clinically significant abnormalities or co-morbidiites, other than HCV infection, that make the subject unsuitable for this study or treatment.
4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegIFN, ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or NS5A inhibitors.
5. History of solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: HCV RNA early viral load decline in the plasma following combination of ombitasvir/ABT-450/r and dasabuvir administered with low dose, full dose, or no RBV in treatment-naive HCV genotype GT 1a-infected adults;Secondary Objective: None;Primary end point(s): The slope of the second phase decline in plasma HCV RNA levels during treatment.;Timepoint(s) of evaluation of this end point: From Week 0 to Week 2

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None