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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

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: NCT02442284
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : August 30, 2017
Last Update Posted : October 16, 2017
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
Cirrhosis
Hepatitis C Virus
Interventions Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug: Ribavirin
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Period Title: Overall Study
Started 99
Completed 92
Not Completed 7
Reason Not Completed
Adverse Event             1
Withdrew Consent             2
Lost to Follow-up             3
Other             1
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Overall Number of Baseline Participants 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants
61.5  (5.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Female
4
   4.0%
Male
95
  96.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description:
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Overall Number of Participants Analyzed 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.9
(87.4 to 97.2)
2.Secondary Outcome
Title Percentage of Participants With Virologic Failure During Treatment
Hide Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.
Time Frame up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description:
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Overall Number of Participants Analyzed 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.0
(0.2 to 5.5)
3.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Time Frame From the end of treatment through 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description:
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Overall Number of Participants Analyzed 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.2
(0.6 to 7.7)
4.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders.
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description:
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.8
(86.0 to 98.8)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks for participants treated for 12 weeks and up to 28 weeks for participants treated for 24 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
 
Arm/Group Title 3-DAA ± RBV for 12 or 24 Weeks
Hide Arm/Group Description 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
All-Cause Mortality
3-DAA ± RBV for 12 or 24 Weeks
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
3-DAA ± RBV for 12 or 24 Weeks
Affected / at Risk (%)
Total   7/99 (7.07%) 
Cardiac disorders   
MYOCARDIAL INFARCTION  1  1/99 (1.01%) 
Gastrointestinal disorders   
PANCREATITIS  1  1/99 (1.01%) 
General disorders   
DRUG INTERACTION  1  1/99 (1.01%) 
Hepatobiliary disorders   
CHOLANGITIS  1  1/99 (1.01%) 
CHOLECYSTITIS  1  1/99 (1.01%) 
Infections and infestations   
GASTROENTERITIS VIRAL  1  1/99 (1.01%) 
PNEUMONIA  1  1/99 (1.01%) 
Psychiatric disorders   
DEPRESSIVE SYMPTOM  1  1/99 (1.01%) 
MENTAL STATUS CHANGES  1  1/99 (1.01%) 
SCHIZOPHRENIA  1  1/99 (1.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3-DAA ± RBV for 12 or 24 Weeks
Affected / at Risk (%)
Total   58/99 (58.59%) 
Blood and lymphatic system disorders   
ANAEMIA  1  5/99 (5.05%) 
Gastrointestinal disorders   
DIARRHOEA  1  9/99 (9.09%) 
NAUSEA  1  15/99 (15.15%) 
General disorders   
FATIGUE  1  28/99 (28.28%) 
OEDEMA PERIPHERAL  1  5/99 (5.05%) 
Investigations   
HAEMOGLOBIN DECREASED  1  6/99 (6.06%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  6/99 (6.06%) 
BACK PAIN  1  6/99 (6.06%) 
Nervous system disorders   
DIZZINESS  1  8/99 (8.08%) 
HEADACHE  1  20/99 (20.20%) 
Psychiatric disorders   
ANXIETY  1  5/99 (5.05%) 
INSOMNIA  1  10/99 (10.10%) 
IRRITABILITY  1  5/99 (5.05%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  8/99 (8.08%) 
Skin and subcutaneous tissue disorders   
PRURITUS  1  10/99 (10.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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: NCT02442284    
Other Study ID Numbers: M14-251
First Submitted: May 11, 2015
First Posted: May 13, 2015
Results First Submitted: July 31, 2017
Results First Posted: August 30, 2017
Last Update Posted: October 16, 2017