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A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01995071
First Posted: November 26, 2013
Last Update Posted: October 16, 2017
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.
Information provided by (Responsible Party):
AbbVie
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Hepatitis C
Hepatitis C Virus
Compensated Cirrhosis
Interventions: Drug: ABT-493
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Drug: Ribavirin (RBV)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1 Non-cirrhotic ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 2 Non-cirrhotic ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 3 Non-cirrhotic ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 4 Non-cirrhotic ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 5 Compensated Cirrhotic ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 6 Non-cirrhotic ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 7 Non-cirrhotic ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 8 Non-cirrhotic ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 9 Non-cirrhotic ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 10 Compensated Cirrhotic ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 11 Non-cirrhotic ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 12 Non-cirrhotic ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Participant Flow:   Overall Study
    Arm 1 Non-cirrhotic   Arm 2 Non-cirrhotic   Arm 3 Non-cirrhotic   Arm 4 Non-cirrhotic   Arm 5 Compensated Cirrhotic   Arm 6 Non-cirrhotic   Arm 7 Non-cirrhotic   Arm 8 Non-cirrhotic   Arm 9 Non-cirrhotic   Arm 10 Compensated Cirrhotic   Arm 11 Non-cirrhotic   Arm 12 Non-cirrhotic
STARTED [1]   8   8   9   8   8   8   8   8   8   8   8   0 
COMPLETED   7   8   8   8   7   8   7   6   7   8   7   0 
NOT COMPLETED   1   0   1   0   1   0   1   2   1   0   1   0 
Adverse Event                0                0                0                0                0                0                1                0                0                0                0                0 
Moved                0                0                1                0                1                0                0                0                0                0                1                0 
Lost to Follow-up                1                0                0                0                0                0                0                1                1                0                0                0 
Incarcerated                0                0                0                0                0                0                0                1                0                0                0                0 
[1] The safety population: all participants who received at least 1 dose of any study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population: all participants who received at least 1 dose of any study drug.

Reporting Groups
  Description
Arm 1 Non-cirrhotic ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 2 Non-cirrhotic ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 3 Non-cirrhotic ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 4 Non-cirrhotic ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 5 Compensated Cirrhotic ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 6 Non-cirrhotic ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 7 Non-cirrhotic ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 8 Non-cirrhotic ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 9 Non-cirrhotic ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 10 Compensated Cirrhotic ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 11 Non-cirrhotic ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Arm 12 Non-cirrhotic ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Arm 1 Non-cirrhotic   Arm 2 Non-cirrhotic   Arm 3 Non-cirrhotic   Arm 4 Non-cirrhotic   Arm 5 Compensated Cirrhotic   Arm 6 Non-cirrhotic   Arm 7 Non-cirrhotic   Arm 8 Non-cirrhotic   Arm 9 Non-cirrhotic   Arm 10 Compensated Cirrhotic   Arm 11 Non-cirrhotic   Arm 12 Non-cirrhotic   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   9   8   8   8   8   8   8   8   8   0   89 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (5.20)   55.8  (9.53)   50.3  (9.04)   52.6  (6.37)   58.6  (6.14)   53.9  (9.34)   50.6  (12.60)   49.4  (15.31)   60.5  (5.61)   55.3  (9.63)   54.6  (5.15)      54.1  (9.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                         
Female      3  37.5%      2  25.0%      0   0.0%      3  37.5%      1  12.5%      3  37.5%      0   0.0%      2  25.0%      2  25.0%      3  37.5%      4  50.0%         23  25.8% 
Male      5  62.5%      6  75.0%      9 100.0%      5  62.5%      7  87.5%      5  62.5%      8 100.0%      6  75.0%      6  75.0%      5  62.5%      4  50.0%         66  74.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment   [ Time Frame: Day 1 through prior to first dose of the combination regimen on Study Day 4 ]

2.  Secondary:   Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)   [ Time Frame: 12 weeks after last actual dose of combination study drug ]

3.  Secondary:   Percentage of Participants With On-treatment Virologic Failure   [ Time Frame: Up to 87 days ]

4.  Secondary:   Percentage of Participants With Post-treatment Relapse   [ Time Frame: From the end of treatment through 12 weeks after the last dose of combination study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01995071     History of Changes
Other Study ID Numbers: M13-595
First Submitted: November 21, 2013
First Posted: November 26, 2013
Results First Submitted: August 17, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017