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Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01563536
First received: January 27, 2012
Last updated: December 29, 2014
Last verified: December 2014
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-267
Drug: ABT-450
Drug: ABT-333
Drug: Ritonavir
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks

Participant Flow:   Overall Study
    ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV     ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV  
STARTED     6     6  
COMPLETED     5     4  
NOT COMPLETED     1     2  
Withdrawal by Subject                 0                 2  
Lost to Follow-up                 1                 0  



  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.
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Reporting Groups
  Description
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Total Total of all reporting groups

Baseline Measures
    ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV     ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
Mean (Standard Deviation)
  51.5  (4.76)     46.8  (11.84)     49.2  (8.94)  
Gender  
[units: participants]
     
Female     4     3     7  
Male     2     3     5  



  Outcome Measures
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1.  Primary:   Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1   [ Time Frame: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose) ]

2.  Primary:   Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1   [ Time Frame: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose) ]

3.  Primary:   Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1   [ Time Frame: Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose) ]

4.  Primary:   Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3   [ Time Frame: Day 2 (pre-dose) and Day 3 (pre-dose) ]

5.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks). ]

6.  Primary:   Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy   [ Time Frame: Pre-dose on Days 1, 2, and 3 ]

7.  Secondary:   Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy   [ Time Frame: 12 and 24 weeks after last dose of combination study drug ]

8.  Secondary:   Percentage of Participants With Rapid Virologic Response   [ Time Frame: 4 weeks ]

9.  Secondary:   Percentage of Participants With End-of-Treatment Response   [ Time Frame: 12 weeks ]

10.  Secondary:   Percentage of Participants With Extended Rapid Virologic Response   [ Time Frame: Weeks 4 to 12 ]

11.  Secondary:   Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy   [ Time Frame: Predose on Days 1, 2, and 3 ]

12.  Other Pre-specified:   Resistance-Associated Variants and Phenotypic Resistance   [ Time Frame: Day 1 Pre-dose (Baseline) and Day 3 Pre-dose ]


  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



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01563536     History of Changes
Other Study ID Numbers: M13-386
Study First Received: January 27, 2012
Results First Received: December 29, 2014
Last Updated: December 29, 2014
Health Authority: United States: Food and Drug Administration