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Completed

NCT Number: NCT02292719

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

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.

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Key information

Conditions

Chronic Hepatitis C Virus Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic HCV infection prior to study enrollment.
  • Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
  • Absence OR presence of cirrhosis.
  • If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

Exclusion criteria

  • Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
  • 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).
  • Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
  • Abnormal lab tests.
  • Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Treatment and study plan

OBV/PTV/r

Drug

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

Sofosbuvir

Drug

Tablet

Other names: Sovaldi

ribavirin (RBV)

Drug

Tablet

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: Quartz II/III

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2014
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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