A study to evaluate the safety and efficacy of ombitasvir/ABT-450/ritonavir with sofosbuvir with or without ribavirin in adults with Chronic Hepatitis C Virus infection.

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003147-35-GB

Enrollment

Registered

2014-10-23

Start date

2014-12-16

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Virus (HCV) Infection MedDRA version: 20.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: ombitasvir/ABT-450/ritonavir Product Code: ABT-267/ABT-450/r Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABT-450

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic HCV infection prior to study enrollment. 2. Screening laboratory results from the central clinical laboratory indicating either HCV genotype 2 or 3 infection only (no mixed genotype). 3. Absence OR presence of cirrhosis. 4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC). 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 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: 1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody 2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse. 3. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267), simeprevir, ledipasvir and daclatasvir. 4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis. 5. Abnormal lab tests. 6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant.

Design outcomes

Primary

Measure	Time frame
Main Objective: Percentage of subjects with sustained virologic response 12 weeks post-treatment.; Secondary Objective: 1. Percentage of subjects with on-treatment virologic failure in each treatment arm 2. Percentage of subjects with virologic relapse after treatment in each treatment arm ;Primary end point(s): Percentage of subjects with sustained virologic response 12 weeks post-treatment.;Timepoint(s) of evaluation of this end point: 12 weeks after the last dose of active drug.	—

Measure

Time frame

Main Objective: Percentage of subjects with sustained virologic response 12 weeks post-treatment.; Secondary Objective: 1. Percentage of subjects with on-treatment virologic failure in each treatment arm 2. Percentage of subjects with virologic relapse after treatment in each treatment arm ;Primary end point(s): Percentage of subjects with sustained virologic response 12 weeks post-treatment.;Timepoint(s) of evaluation of this end point: 12 weeks after the last dose of active drug.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Percentage of subjects with on-treatment virologic failure in each treatment arm 2. Percentage of subjects with virologic relapse after treatment in each treatment arm ; Timepoint(s) of evaluation of this end point: - All visits from 6 weeks after first dose (for 12-week and 8-week treatment) or at least 26 days of treatment (6 week treatment) to 6, 8, or 12 weeks after first dose - 12 weeks after the last actual dose of active study drug	—

Measure

Time frame

Secondary end point(s): 1. Percentage of subjects with on-treatment virologic failure in each treatment arm 2. Percentage of subjects with virologic relapse after treatment in each treatment arm ; Timepoint(s) of evaluation of this end point: - All visits from 6 weeks after first dose (for 12-week and 8-week treatment) or at least 26 days of treatment (6 week treatment) to 6, 8, or 12 weeks after first dose - 12 weeks after the last actual dose of active study drug

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Countries

Australia, Canada, New Zealand, United Kingdom

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Inc.

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026