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Clinical Trials

MainTitle

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02219503

First received: August 15, 2014
Last updated: May 23, 2016
Last Verified: May 2016
History of Changes
Purpose

Purpose

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Condition Intervention Phase
Chronic Hepatitis C Infection
Compensated Cirrhosis

Drug : Ombitasvir/Paritaprevir/Ritonavir
Drug : Dasabuvir
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment [ Time Frame: Post-treatment Day 1 to Post-treatment Week 12 ]
    Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
Secondary Outcome Measures:
  • Percentage of Participants With On-Treatment Virologic Failure [ Time Frame: Day 1 through Week 12 ]
    On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 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 active study drug duration ≥ 36 days] of treatment.
  • Percentage of Participants With Post-Treatment Relapse [ Time Frame: Post-treatment Day 1 to Post-treatment Week 12 ]
    Post- Treatment Relapse 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 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.

Enrollment: 60
Study Start Date: September 2014
Study Completion Date: September 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks
Drug: Ombitasvir/Paritaprevir/Ritonavir

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Other Name:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • Ritonavir also known as norvir

Drug: Dasabuvir

Tablet

Other Name: ABT-333

Detailed Description:

This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
    • Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
    • HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
  2. Screening laboratory result indicating HCV genotype 1b-infection.
  3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

  • Exclusion Criteria:
  • Women who are pregnant or breastfeeding.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
  • Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
  • Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
  • Use of contraindicated medications within 2 weeks of dosing
  • Screening laboratory analyses showing any of the following abnormal laboratory results:
    • Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
    • Albumin < 2.8 g/dL
    • International normalized ratio (INR) > 1.8. Participants with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
    • Hemoglobin < 10 g/dL
    • Platelets < 25,000 cells per mm3
    • Total bilirubin > 3.0 mg/dL

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02219503

    Sponsors and Collaborators

    AbbVie

    Investigators

    Study Director: Roger Trinh, MD AbbVie
    More Information

    More Information

    Additional Information:

    Related Info

    Responsible Party: AbbVie  
    ClinicalTrials.gov Identifier: NCT02219503   History of Changes  
    Other Study ID Numbers: M14-490  
      2014-001953-18  
    Study First Received: August 15, 2014  
    Last Updated: May 23, 2016  

    Keywords provided by AbbVie:

    Hepatitis C
    Chronic Hepatitis C
    Compensated Cirrhosis
    Cirrhotic
    Hepatitis C Genotype 1b
    Hepatitis C Virus
    Interferon-Free
    Child Pugh A
    Ribavirin-Free

    Additional relevant MeSH terms:
    Infection
    Communicable Diseases
    Hepatitis
    Hepatitis A
    Hepatitis C
    Hepatitis, Chronic
    Fibrosis
    Liver Cirrhosis
    Hepatitis C, Chronic
    Ritonavir

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.