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 (Quartz II/III)

July 8, 2021 updated by: AbbVie

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

The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chronic HCV infection prior to study enrollment.
  2. Screening laboratory results from the central clinical laboratory indicating 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)

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 enrollment 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).
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (genotype [GT]3, noncirrhotic)
Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi
Experimental: Arm B (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
Drug: Ribavirin (RBV)
Tablet
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi
Experimental: Arm C (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
Drug: Ribavirin (RBV)
Tablet
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi
Experimental: Arm D (GT2, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
Drug: Ribavirin (RBV)
Tablet
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi
Experimental: Arm E (GT3, cirrhotic)
OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
Drug: Ribavirin (RBV)
Tablet
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi
Experimental: Arm F (GT3, noncirrhotic)
OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Drug: OBV/PTV/r
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ritonavir (r) also known as Norvir
  • VIEKIRAX combination tablets
  • TECHNIVIE
Drug: Sofosbuvir
Tablet
Other Names:
  • Sovaldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time Frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Up to Week 12
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Up to Week 12
Percentage of Participants With Post-treatment Relapse
Time Frame: Up to 12 weeks after the last actual dose of active study drug
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Up to 12 weeks after the last actual dose of active study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Mariem Charafeddine, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2014

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

July 14, 2017

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-567
  • 2014-003147-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C Virus Infection

Clinical Trials on Ribavirin (RBV)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe