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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

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ClinicalTrials.gov Identifier: NCT02604017
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
HCV
Intervention: Drug: ABT-493/ABT-530

  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
This study included a 35-day screening period.

Reporting Groups
  Description
ABT-493/ABT-530 for 12 Weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Participant Flow:   Overall Study
    ABT-493/ABT-530 for 12 Weeks   ABT-493/ABT-530 for 8 Weeks
STARTED [1]   352   351 
COMPLETED   346   343 
NOT COMPLETED   6   8 
Withdrew Consent                0                2 
Lost to Follow-up                5                6 
Not Specified                1                0 
[1] Intent-to-treat population: all participants who received at least 1 dose of study drug.



  Baseline Characteristics

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 participants who received at least 1 dose of study drug (ITT population).

Reporting Groups
  Description
ABT-493/ABT-530 for 12 Weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
ABT-493/ABT-530 for 8 Weeks ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   ABT-493/ABT-530 for 12 Weeks   ABT-493/ABT-530 for 8 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 352   351   703 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.27  (11.62)   51.58  (11.90)   50.93  (11.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   176   184   360 
Male   176   167   343 


  Outcome Measures

1.  Primary:   Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm   [ Time Frame: 12 weeks after the last actual dose of study drug ]

2.  Primary:   Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later   [ Time Frame: 12 weeks after last actual dose of study drug ]

3.  Primary:   Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants   [ Time Frame: 12 weeks after the last actual dose of study drug ]

4.  Secondary:   Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants   [ Time Frame: 12 weeks after last actual dose of study drug ]

5.  Secondary:   Percentage of Participants With SVR12   [ Time Frame: 12 weeks after last actual dose of study drug ]

6.  Secondary:   Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants   [ Time Frame: 12 weeks after last actual dose of study drug ]

7.  Secondary:   Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants   [ Time Frame: 12 weeks after last actual dose of study drug ]

8.  Secondary:   Percentage of Participants With On-treatment Virologic Failure   [ Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment ]

9.  Secondary:   Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants   [ Time Frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment ]

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

11.  Secondary:   Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants   [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT02604017     History of Changes
Other Study ID Numbers: M13-590
2015-002087-17 ( EudraCT Number )
First Submitted: November 11, 2015
First Posted: November 13, 2015
Results First Submitted: August 17, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017