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Completed

NCT Number: NCT02068222

A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

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Key information

About this study

Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
  • Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
  • Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
  • Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion criteria

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
  • Prior therapy for the treatment of HCV.
  • Any current or past clinical evidence of cirrhosis.
  • Any cause of liver disease other than chronic HCV-infection.
  • HCV genotype co-infection with any other HCV genotype.
  • Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Treatment and study plan

ABT-450/ritonavir (r)

Drug

Tablet

Other names: ABT-450 also known as paritaprevir

ABT-530

Drug

Tablet

Other names: pibrentasvir

ribavirin (RBV)

Drug

Tablet

Primary outcomes

  1. The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)

    Time frame: 12 weeks after last dose of study drug

    SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.

Secondary outcomes

  1. The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)

    Time frame: 24 weeks after last dose of study drug

    SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.

  2. The Percentage of Subjects With Virologic Failure During Treatment

    Time frame: Up to Treatment Week 12

    Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.

  3. The Percentage of Subjects With Post-Treatment Relapse

    Time frame: Within 12 weeks after the last dose of study drug

    Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Feb 22, 2018

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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