Phase 3
Completed N=478
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
Source: ClinicalTrials.gov NCT01773070 ↗Enrolled (actual)
478
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection — 0.2; 0.2 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: 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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection |
0.2; 0.2 | — |
| PRIMARY Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B |
7; 0; 13; 10; 6; 4 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection |
2.0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection |
0.2; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection |
2.2; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
- The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
- The subject must voluntarily sign and date the informed consent form.
- Subject completed the post-treatment period of an eligible prior study.
Exclusion Criteria
- The investigator considers the subject unsuitable for the study for any reasons.
- Receipt of any investigational product from Day 1 and while enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT01773070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.