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Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01314261
First received: March 11, 2011
Last updated: January 21, 2015
Last verified: January 2015
Results First Received: December 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Hepatitis C
Hepatitis C Virus (HCV) Infection
Interventions: Drug: ABT-267
Drug: Pegylated interferon (pegIFN)
Drug: Ribavirin (RBV)
Other: Placebo for ABT-267

  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 (5 mg) Once Daily + pegIFN/RBV Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (50 mg) Once Daily + pegIFN/RBV Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (200 mg) Once Daily + pegIFN/RBV Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Participant Flow:   Overall Study
    ABT-267 (5 mg) Once Daily + pegIFN/RBV     ABT-267 (50 mg) Once Daily + pegIFN/RBV     ABT-267 (200 mg) Once Daily + pegIFN/RBV     Placebo + pegIFN/RBV  
STARTED     9     9     10     9  
Discontinued ABT-267 or Placebo     1     0     1     0  
Discontinued pegIFN/RBV     1     4     5     1  
COMPLETED     7     5     7     6  
NOT COMPLETED     2     4     3     3  
Adverse Event                 1                 0                 0                 0  
Withdrawal by Subject                 0                 3                 1                 0  
Lost to Follow-up                 1                 0                 2                 2  
Virologic Failure                 0                 1                 0                 1  



  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.
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.

Reporting Groups
  Description
ABT-267 (5 mg) Once Daily + pegIFN/RBV Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (50 mg) Once Daily + pegIFN/RBV Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
ABT-267 (200 mg) Once Daily + pegIFN/RBV Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Placebo + pegIFN/RBV Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Total Total of all reporting groups

Baseline Measures
    ABT-267 (5 mg) Once Daily + pegIFN/RBV     ABT-267 (50 mg) Once Daily + pegIFN/RBV     ABT-267 (200 mg) Once Daily + pegIFN/RBV     Placebo + pegIFN/RBV     Total  
Number of Participants  
[units: participants]
  9     9     10     9     37  
Age  
[units: years]
Mean (Standard Deviation)
  50.1  (11.32)     49.2  (9.55)     46.0  (10.26)     48.1  (12.32)     48.3  (10.55)  
Gender  
[units: participants]
         
Female     5     2     4     4     15  
Male     4     7     6     5     22  



  Outcome Measures
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1.  Primary:   Percentage of Participants With 4-week Rapid Virologic Response (RVR)   [ Time Frame: Week 4 ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of ABT-267   [ Time Frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) ]

3.  Primary:   Time to Maximum Plasma Concentration (Tmax) of ABT-267   [ Time Frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose) ]

4.  Primary:   Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267   [ Time Frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12 ]

5.  Primary:   Plasma Concentrations of Ribavirin (RBV)   [ Time Frame: At each study visit from Week 1 to Week 12 ]

6.  Primary:   Serum Concentrations of Pegylated Interferon (pegIFN)   [ Time Frame: At each study visit from Week 1 to Week 12 ]

7.  Secondary:   Percentage of Participants With Partial Early Virologic Response (pEVR)   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Percentage of Participants With Complete Early Virologic Response (cEVR)   [ Time Frame: Week 12 ]

9.  Secondary:   Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing   [ Time Frame: 12 weeks after the last dose of pegIFN/RBV ]

10.  Secondary:   Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing   [ Time Frame: 24 weeks after the last dose of pegIFN/RBV ]

11.  Secondary:   Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)   [ Time Frame: Approximately 12 weeks ]

12.  Secondary:   Percentage of Participants With Extended Rapid Virologic Response (eRVR)   [ Time Frame: Week 4 through Week 12 ]


  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 (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01314261     History of Changes
Other Study ID Numbers: M12-114
Study First Received: March 11, 2011
Results First Received: December 29, 2014
Last Updated: January 21, 2015
Health Authority: United States: Food and Drug Administration