A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/15/2019 |
Start Date: | June 22, 2015 |
End Date: | July 13, 2020 |
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
This is a rollover study to assess resistance and durability of response to ABT-493 and/or
ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents
for the treatment of chronic HCV.
ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents
for the treatment of chronic HCV.
Inclusion Criteria:
1. The subject is male or female 18 years of age or older
2. The subject has received at least one dose of an ABT-493- and/or ABT 530 containing
regimen in a prior AbbVie HCV Phase 2 or 3 study
3. The interval between the last dose of the AbbVie DAA therapy from the previous
clinical study and enrollment in Study M13-576 must be no longer than 2 years for
subjects who have not been retreated. Subject who have been treated with a
commercially available anti-HCV treatment may be enrolled greater than 2 years after
the last dose of the AbbVie DAA therapy from the previous clinical study.
4. The subject must voluntarily sign and date the informed consent form approved by an
Independent Review Board or Ethics Committee prior to the initiation of any
study-specific procedures.
5. Subject completed the post-treatment period of an eligible prior study.
Exclusion Criteria:
1. The investigator considers the subject unsuitable for the study for any reasons (e.g.,
failure to comply with study procedures in the prior AbbVie clinical study).
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or
ABT-530 in the prior study.
3. Subjects who experienced non-virologic treatment failure due to premature
discontinuation of study drug in prior study of ABT-493/ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic
failure in the prior Phase 2 or 3 study
We found this trial at
21
sites
480 Honeysuckle Road
Dothan, Alabama 36305
Dothan, Alabama 36305
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