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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02219503
Recruitment Status : Completed
First Posted : August 19, 2014
Results First Posted : June 29, 2016
Last Update Posted : July 12, 2021
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Compensated Cirrhosis Drug: Ombitasvir/Paritaprevir/Ritonavir Drug: Dasabuvir Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
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)
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • Ritonavir also known as norvir

Drug: Dasabuvir
Other Name: ABT-333

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
  3. 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.
  4. 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.)
  5. Use of contraindicated medications within 2 weeks of dosing
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02219503

Sponsors and Collaborators
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Study Director: Roger Trinh, MD AbbVie
Additional Information:
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Responsible Party: AbbVie Identifier: NCT02219503    
Other Study ID Numbers: M14-490
2014-001953-18 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Results First Posted: June 29, 2016
Last Update Posted: July 12, 2021
Last Verified: July 2021
Keywords provided by AbbVie:
Hepatitis C
Chronic Hepatitis C
Compensated Cirrhosis
Hepatitis C Genotype 1b
Hepatitis C Virus
Child Pugh A
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents