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Completed

NCT Number: NCT02582632

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Virus Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic HCV infection at Screening.
  • Screening laboratory result indicating HCV genotype 1b infection.
  • Treatment-naïve and non-cirrhotic.

Exclusion criteria

  • HCV genotype or subtype other than GT1b.
  • Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
  • Any current or past clinical evidence of cirrhosis.
  • Screening laboratory analyses that shows abnormal results.
  • Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Treatment and study plan

Ombitasvir/paritaprevir/ritonavir

Drug

Tablet

Other names: ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450

Dasabuvir

Drug

Tablet

Other names: ABT-333

Primary outcomes

  1. Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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

    SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Secondary outcomes

  1. Percentage of Participants With On-Treatment Virologic Failure During Treatment Period

    Time frame: Up to 8 weeks while on treatment

    On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.

  2. Percentage of Participants With Post-Treatment Relapse12

    Time frame: Up to 12 weeks after last dose of study drug

    Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.

  3. Percentage of Female Participants Responding With SVR12

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

    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

  4. Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12

    Time frame: Baseline and 12 weeks after the last actual dose of study drug

    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Other outcomes

  1. Percentage of Participants Who Achieve SVR12: mITT-GT Population

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

    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

  2. Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population

    Time frame: Up to 8 weeks while on treatment

    On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.

  3. Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population

    Time frame: Up to 12 weeks after last dose of study drug

    Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.

  4. Percentage of Female Participants Responding With SVR12: mITT-GT Population

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

    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

  5. Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population

    Time frame: Baseline and 12 weeks after the last actual dose of study drug

    SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

Acronym: GARNET

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2015
Registry last updated
Jul 30, 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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