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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.
 
ClinicalTrials.gov Identifier: NCT02219503
Recruitment Status : Completed
First Posted : August 19, 2014
Results First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C Infection
Compensated Cirrhosis
Interventions Drug: Ombitasvir/Paritaprevir/Ritonavir
Drug: Dasabuvir
Enrollment 60
Recruitment Details A total of 60 subjects were enrolled and all the subjects completed the study. All 60 subjects were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.
Pre-assignment Details  
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
Baseline analyses included all participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
59.5  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
23
  38.3%
Male
37
  61.7%
Interleukin 28B (IL28B) Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
CC 10
CT 36
TT 14
Missing 0
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Hide Description

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.

Time Frame Post-treatment Day 1 to Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description:
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(94.0 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 100
Confidence Interval (2-Sided) 95%
94.0 to 100.0
Estimation Comments 95% confidence interval (CI) was calculated using Wilson score method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Comments The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 100
Confidence Interval (2-Sided) 95%
94.0 to 100.0
Estimation Comments 95% confidence interval (CI) was calculated using Wilson score method.
2.Secondary Outcome
Title Percentage of Participants With On-Treatment Virologic Failure
Hide Description 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.
Time Frame Day 1 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description:
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 6.0)
3.Secondary Outcome
Title Percentage of Participants With Post-Treatment Relapse
Hide Description 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.
Time Frame Post-treatment Day 1 to Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description:
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 6.0)
Time Frame AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Hide Arm/Group Description Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
All-Cause Mortality
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Affected / at Risk (%)
Total   1/60 (1.67%) 
Nervous system disorders   
SYNCOPE  1  1/60 (1.67%) 
Vascular disorders   
HYPOTENSION  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir
Affected / at Risk (%)
Total   39/60 (65.00%) 
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER  1  3/60 (5.00%) 
DIARRHOEA  1  12/60 (20.00%) 
DYSPEPSIA  1  4/60 (6.67%) 
NAUSEA  1  4/60 (6.67%) 
General disorders   
FATIGUE  1  13/60 (21.67%) 
Infections and infestations   
INFLUENZA  1  4/60 (6.67%) 
NASOPHARYNGITIS  1  4/60 (6.67%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  6/60 (10.00%) 
MYALGIA  1  4/60 (6.67%) 
Nervous system disorders   
DIZZINESS  1  6/60 (10.00%) 
HEADACHE  1  11/60 (18.33%) 
Psychiatric disorders   
INSOMNIA  1  6/60 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  4/60 (6.67%) 
Skin and subcutaneous tissue disorders   
PRURITUS  1  6/60 (10.00%) 
PRURITUS GENERALISED  1  3/60 (5.00%) 
Vascular disorders   
HYPERTENSION  1  3/60 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02219503    
Other Study ID Numbers: M14-490
2014-001953-18 ( EudraCT Number )
First Submitted: August 15, 2014
First Posted: August 19, 2014
Results First Submitted: May 23, 2016
Results First Posted: June 29, 2016
Last Update Posted: June 29, 2016