A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
Have a question?
You can ask us questions via online form or phone call.
Call us @: 844 663-3742
| Location | Status | Site Contact Details |
|---|
This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
Time Frame: From the end of treatment in the previous study up to 3 years post-treatment
Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen
Time Frame: From the end of treatment in the previous study up to 3 years post-treatment
Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure
Time Frame: From Day 1 to Month 12
Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection
Time Frame: After Day 1 up to 3 years post-treatment
Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time
Time Frame: From Day 1 up to 3 years post-treatment
Mean FibroTest Score Over Time
Time Frame: From Day 1 up to 3 years post-treatment
Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time
Time Frame: From Day 1 up to 3 years post-treatment
Mean FibroScan Scores Over Time
Time Frame: Up to 3 years post-treatment
Interventions:
- Drug: ABT-493
- Drug: ABT-530
Enrollment:
384
Available Documents
FaFilePdfUnmappedFaFilePdfUnmappedFaFilePdfScientific Result Summary (English)FaFilePdfPlain Language Summary (English)FaFilePdfPlain Language Summary (Dutch)FaFilePdfPlain Language Summary (German)FaFilePdfPlain Language Summary (Spanish)Additional Information
Watch a video to learn more about what you may experience as a clinical trial volunteer: /resources/what-happens-in-a-clinical-trial
Take a virtual reality screening visit tour to an example of a clinical trial site: /resources/screening-visit-virtual-tour
Use a questionnaire tool to think through questions to ask yourself about participating in a clinical trial and print out your responses to discuss with your partners in your health journey: /resource-information-clinical-trial-community/decision-counselor