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Trial record 96 of 2130 for:    Hepatitis C

A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

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: NCT01773070
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : November 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hepatitis C
Interventions Drug: ABT-450/ritonavir
Drug: ABT-333
Drug: ABT-267
Enrollment 478
Recruitment Details This follow-up study was open to participants from AbbVie studies M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)’ M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic hepatitis C virus (HCV), followed for up to 3 years post-treatment.
Period Title: Overall Study
Started 478
Completed 397
Not Completed 81
Reason Not Completed
Withdrawal by Subject             24
Lost to Follow-up             39
Other             15
Death (unrelated to study procedures)             3
Arm/Group Title All Participants
Hide Arm/Group Description Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Baseline Participants 478
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 478 participants
53.0  (9.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants
Female
227
  47.5%
Male
251
  52.5%
1.Primary Outcome
Title Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection
Hide Description Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.
Time Frame Up to 3 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved SVR12 and had post-SVR12 HCV RNA data available. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Participants Analyzed 457
Measure Type: Number
Unit of Measure: percentage of participants
Relapse12overall With New HCV Infection 0.2
Relapse12overall Without New HCV Infection 0.2
2.Primary Outcome
Title Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
Hide Description The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.
Time Frame from the last dose of study drug in the previous study up to 3 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had post-baseline sequencing data for NS3, NS5A, or NS5B at given time point.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
NS3: time of failure Number Analyzed 18 participants
7
  38.9%
NS3: post-treatment week 48 Number Analyzed 7 participants
0
   0.0%
NS5A: time of failure Number Analyzed 18 participants
13
  72.2%
NS5A: post-treatment week 48 Number Analyzed 10 participants
10
 100.0%
NS5A: post-treatment week 96 Number Analyzed 8 participants
6
  75.0%
NS5A: post-treatment week 132 Number Analyzed 8 participants
4
  50.0%
NS5B: time of failure Number Analyzed 15 participants
7
  46.7%
NS5B: post-treatment week 24 Number Analyzed 4 participants
3
  75.0%
NS5B: post-treatment week 96 Number Analyzed 5 participants
1
  20.0%
3.Secondary Outcome
Title Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
Hide Description Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
Time Frame From the end of treatment through 12 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Participants Analyzed 458
Measure Type: Number
Unit of Measure: percentage of participants
Relapse12 Without New HCV Infection 2.0
Relapse12 With New HCV Infection 0
4.Secondary Outcome
Title Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
Hide Description Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.
Time Frame From the end of treatment through 24 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved SVR12 and had HCV RNA data available in the SVR24 window. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Participants Analyzed 403
Measure Type: Number
Unit of Measure: percentage of participants
Relapse24 Without New HCV Infection 0.2
Relapse24 With New HCV Infection 0
5.Secondary Outcome
Title Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection
Hide Description Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
Time Frame Up to 3 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Overall Number of Participants Analyzed 458
Measure Type: Number
Unit of Measure: percentage of participants
Relapse˅overall Without New HCV Infection 2.2
Relapse˅overall With New HCV Infection 0.2
Time Frame From last dose of direct-acting antiviral agent treatment in the previous study to last HCV RNA assessment in M13-102 (mean [SD] duration: 146.3 [28.16] weeks).
Adverse Event Reporting Description Per protocol, only serious adverse events that the investigator considered to be causally related to study procedures (i.e., venipunctures) were collected in this study. Non-serious adverse events were not collected.
 
Arm/Group Title All Participants
Hide Arm/Group Description Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   3/478 (0.63%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/478 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/478 (0.00%) 
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
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01773070     History of Changes
Other Study ID Numbers: M13-102
2012-003073-26 ( EudraCT Number )
First Submitted: November 19, 2012
First Posted: January 23, 2013
Results First Submitted: October 5, 2017
Results First Posted: November 6, 2017
Last Update Posted: December 6, 2017