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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

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ClinicalTrials.gov Identifier: NCT02219477
Recruitment Status : Completed
First Posted : August 19, 2014
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Decompensated Cirrhosis Hepatitis C Virus Drug: ombitasvir/paritaprevir/ritonavir Drug: dasabuvir Drug: ribavirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : June 13, 2016
Actual Study Completion Date : March 3, 2017


Arm Intervention/treatment
Experimental: Group 1: GT1B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
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
tablet
Other Name: ABT-333

Drug: ribavirin
tablet

Experimental: Group 2: GT1 Non-B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
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
tablet
Other Name: ABT-333

Drug: ribavirin
tablet

Experimental: Group 3: GT4
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
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: ribavirin
tablet




Primary Outcome Measures :
  1. Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.


Secondary Outcome Measures :
  1. Percentage of Participants With SVR12 in Group 3 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.

  2. Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure [ Time Frame: Up to 24 weeks during treatment ]
    On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; 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 HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.

  3. Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12 [ Time Frame: Up to 12 weeks after the last actual dose of study drug ]
    Relapse˅12 was 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) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.

  4. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests [ Time Frame: Up to post-treatment Week 12 ]

    Improvement was defined as:

    • increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin
    • decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin
    • decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein
    • increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count
    • decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio.

  5. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest [ Time Frame: Up to post-treatment Week 12 ]
    The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.

  6. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score [ Time Frame: Up to post-treatment Week 12 ]
    The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.

  7. Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score [ Time Frame: Up to post-treatment Week 12 ]
    MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.
  2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography [CT] scan or magnetic resonance imaging [MRI]).
  3. Child-Pugh Score of 7 - 9, inclusive, at time of Screening.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
  3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
  4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or 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. Any current or past evidence of Child-Pugh C classification.

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 ClinicalTrials.gov identifier (NCT number): NCT02219477


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Eric Cohen, MD AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02219477     History of Changes
Other Study ID Numbers: M14-227
2014-001477-13 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Keywords provided by AbbVie:
Cirrhosis
Hepatitis C
Child-Pugh B
Hepatitis C Genotype 4
Interferon-Free
Hepatitis C Genotype 1
Chronic Hepatitis C
Decompensated Cirrhosis
Hepatitis C Virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors