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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-003073-26
Secondary ID [2] 0 0
M13-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Snoring 0 0
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-450/ritonavir
Treatment: Drugs - ABT-333
Treatment: Drugs - ABT-267
Treatment: Devices - Tongue Advancement Retainer Device

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.

Experimental: Device Treatment - Tongue Advancement Retainer Device


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.

Treatment: Devices: Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection
Timepoint [1] 0 0
Up to 3 years post-treatment
Primary outcome [2] 0 0
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
Timepoint [2] 0 0
from the last dose of study drug in the previous study up to 3 years post-treatment
Primary outcome [3] 0 0
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
Timepoint [3] 0 0
Approximately 6 weeks
Primary outcome [4] 0 0
The safety and tolerability of single and multiple doses of HMPL-504 administered to patients.
Timepoint [4] 0 0
up to 20 months
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
Timepoint [1] 0 0
From the end of treatment through 12 weeks post-treatment
Secondary outcome [2] 0 0
Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
Timepoint [2] 0 0
From the end of treatment through 24 weeks post-treatment
Secondary outcome [3] 0 0
Percentage of Participants Who Experienced Relapse?Overall Without and With New HCV Infection
Timepoint [3] 0 0
Up to 3 years post-treatment
Secondary outcome [4] 0 0
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
Timepoint [4] 0 0
Approximately 6 weeks
Secondary outcome [5] 0 0
Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax .
Timepoint [5] 0 0
Day 1-3 Single Dose and Day 1-21 Steady State

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
478
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Southern Health and Monash Institute of Medical Research - Clayton
Recruitment hospital [4] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Austin Hospital, Melbourne Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT01773070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01773070