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Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada (AMBER)

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: NCT02581189
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborators:
IST GmbH, Germany
Cato Research
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Chronic Hepatitis C
Interventions Drug: Ombitasvir/paritaprevir/ritonavir
Drug: Dasabuvir
Drug: Ribavirin
Enrollment 565
Recruitment Details  
Pre-assignment Details Safety population: all enrolled participants receiving at least 1 dose of the ABBVIE REGIMEN.The prescribed ABBVIE REGIMEN needed to be known. 565 participants enrolled; treatment not started in 28 participants; 3 withdrew consent and no start of treatment was recorded; Two of the 3 deaths noted below occurred during the SAE collection period.
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Period Title: Overall Study
Started 534
Completed 481
Not Completed 53
Reason Not Completed
Failure to return             36
Withdrew consent             5
Death             3
Insufficient virological response             2
Other, not specified             7
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Baseline Participants 534
Hide Baseline Analysis Population Description
Safety population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN. The prescribed ABBVIE REGIMEN needed to be known.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 534 participants
56  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants
Female 179
Male 355
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants
American Indian or Alaska Native 25
Asian 29
Native Hawaiian or Other Pacific Islander 0
Black or African American 19
White 426
More than one race 0
Unknown or Not Reported 35
Hepatitis C genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants
Genotype 1a 286
Genotype 1b 221
Genotype 4 27
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description

SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:

  • evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN
  • an HCV RNA value ≥50 IU/mL at the last measurement post-baseline
  • HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Core population (CP) Number Analyzed 531 participants
86.6
(83.5 to 89.3)
CPSFU12 Number Analyzed 489 participants
94.1
(91.6 to 95.8)
2.Secondary Outcome
Title Percentage of Participants With Virologic Response at End of Treatment (EoT)
Hide Description Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.8
(91.4 to 95.5)
3.Secondary Outcome
Title Percentage of Participants With Relapse
Hide Description Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
Time Frame Up to 48 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.6
(1.5 to 4.5)
4.Secondary Outcome
Title Percentage of Participants With Viral Breakthrough
Hide Description Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.9
(0.3 to 3.4)
5.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Unit of Measure: percentage of participants
1.3
6.Secondary Outcome
Title Percentage of Participants Meeting Relapse Criteria
Hide Description Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Unit of Measure: percentage of participants
2.1
7.Secondary Outcome
Title Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
Hide Description Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Unit of Measure: percentage of participants
2.1
8.Secondary Outcome
Title Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
Hide Description The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)
Arm/Group Title Participants With HCV Genotype 1 or 4
Hide Arm/Group Description:
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
Overall Number of Participants Analyzed 531
Measure Type: Number
Unit of Measure: percentage of participants
6.6
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.Two of the 3 deaths noted below occurred during the SAE collection period.
 
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir Ombitasvir/Paritaprevir/Ritonavir + Ribavirin Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
Hide Arm/Group Description Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) up to 24 weeks Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily) up to 24 weeks Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily) + dasabuvir (tablet; 250 mg twice daily); + weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
All-Cause Mortality
Ombitasvir/Paritaprevir/Ritonavir Ombitasvir/Paritaprevir/Ritonavir + Ribavirin Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/26 (0.00%)   2/210 (0.95%)   1/297 (0.34%) 
Hide Serious Adverse Events
Ombitasvir/Paritaprevir/Ritonavir Ombitasvir/Paritaprevir/Ritonavir + Ribavirin Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   1/26 (3.85%)   9/210 (4.29%)   15/297 (5.05%) 
Cardiac disorders         
Acute Myocardial Infarction  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Myocardial Infarction  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Gastrointestinal disorders         
Nausea  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Pyrexia  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Vomiting  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Abdominal Pain  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Duodenal Ulcer Perforation  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
General disorders         
Drug Withdrawal Syndrome  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Hypothermia  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Oedema Peripheral  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Pyrexia  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Hepatobiliary disorders         
Hepatic Encephalopathy * 1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Hepatic Failure  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Infections and infestations         
Abscess Limb  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Bacteraemia  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Cellulitis  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Infected Cyst  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Pneumonia  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Injury, poisoning and procedural complications         
Toxicity to Various Agents  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Ankle Fracture  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Overdose  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hepatocellular Carcinoma  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Lymphocytic Leukaemia  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Salivary Gland Neoplasm  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Nervous system disorders         
Transient Ischaemic Attack  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Psychiatric disorders         
Psychotic Disorder  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Renal and urinary disorders         
Acute Kidney Injury  1  0/1 (0.00%)  1/26 (3.85%)  0/210 (0.00%)  0/297 (0.00%) 
Chronic Kidney Disease  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Respiratory, thoracic and mediastinal disorders         
Pleural Effusion  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  1/297 (0.34%) 
Pneumothorax  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Pulmonary Oedema  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Skin and subcutaneous tissue disorders         
Rash maculo-papular  1  0/1 (0.00%)  0/26 (0.00%)  1/210 (0.48%)  0/297 (0.00%) 
Skin Ulcer  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Social circumstances         
Alcohol Use  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
Vascular disorders         
Hypotension  1  0/1 (0.00%)  0/26 (0.00%)  0/210 (0.00%)  1/297 (0.34%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ombitasvir/Paritaprevir/Ritonavir Ombitasvir/Paritaprevir/Ritonavir + Ribavirin Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   10/26 (38.46%)   31/210 (14.76%)   102/297 (34.34%) 
Blood and lymphatic system disorders         
Anaemia  1  0/1 (0.00%)  4/26 (15.38%)  0/210 (0.00%)  34/297 (11.45%) 
Gastrointestinal disorders         
Nausea  1  0/1 (0.00%)  1/26 (3.85%)  11/210 (5.24%)  32/297 (10.77%) 
General disorders         
Fatigue  1  0/1 (0.00%)  5/26 (19.23%)  19/210 (9.05%)  48/297 (16.16%) 
Nervous system disorders         
Headache  1  0/1 (0.00%)  3/26 (11.54%)  13/210 (6.19%)  33/297 (11.11%) 
Psychiatric disorders         
Insomnia  1  0/1 (0.00%)  3/26 (11.54%)  1/210 (0.48%)  20/297 (6.73%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02581189    
Other Study ID Numbers: P15-651
First Submitted: October 19, 2015
First Posted: October 20, 2015
Results First Submitted: November 21, 2018
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019