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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01773070
Registration number
NCT01773070
Ethics application status
Date submitted
19/11/2012
Date registered
23/01/2013
Date last updated
6/12/2017
Titles & IDs
Public title
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
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Scientific title
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
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Secondary ID [1]
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2012-003073-26
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Secondary ID [2]
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M13-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABT-450/ritonavir
Treatment: Drugs - ABT-333
Treatment: Drugs - ABT-267
Other: All Participants - 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.
Treatment: Drugs: ABT-450/ritonavir
ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Treatment: Drugs: ABT-333
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Treatment: Drugs: ABT-267
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 3 years post-treatment
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Primary outcome [2]
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Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
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Assessment method [2]
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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.
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Timepoint [2]
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from the last dose of study drug in the previous study up to 3 years post-treatment
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Secondary outcome [1]
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Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
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Assessment method [1]
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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.
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Timepoint [1]
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From the end of treatment through 12 weeks post-treatment
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Secondary outcome [2]
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Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
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Assessment method [2]
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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.
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Timepoint [2]
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From the end of treatment through 24 weeks post-treatment
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Secondary outcome [3]
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Percentage of Participants Who Experienced Relapse?Overall Without and With New HCV Infection
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 3 years post-treatment
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2016
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Sample size
Target
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Accrual to date
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Final
478
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01773070
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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AbbVie Inc
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01773070
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