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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01492504




Registration number
NCT01492504
Ethics application status
Date submitted
30/11/2011
Date registered
15/12/2011
Date last updated
27/11/2019

Titles & IDs
Public title
Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
Scientific title
A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C
Secondary ID [1] 0 0
2011-005287-21
Secondary ID [2] 0 0
AI444-046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

Subjects with chronic hepatitis C - Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C


Treatment: Drugs: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\]
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Durability of Sustained viral response [SVR] (time to loss of virologic response)
Timepoint [1] 0 0
24 or 48-week Intervals
Secondary outcome [1] 0 0
Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12
Timepoint [1] 0 0
24 or 48-week intervals
Secondary outcome [2] 0 0
Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality
Timepoint [2] 0 0
24 or 48-week intervals

Eligibility
Key inclusion criteria
Inclusion Criteria

* Signed Written Informed Consent
* Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
* Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
* Completed the required post-treatment follow-up period in previous study
* Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
* Men and women, ages 18 and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
* Subject must not be participating in any other trial, excluding non-interventional trials
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2018
Sample size
Target
1850
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Darlinghurst Nsw
Recruitment hospital [3] 0 0
Local Institution - Darlinghurst
Recruitment hospital [4] 0 0
Local Institution - Randwick
Recruitment hospital [5] 0 0
Local Institution - Westmead
Recruitment hospital [6] 0 0
Local Institution - Woollongabba
Recruitment hospital [7] 0 0
Local Institution - Adelaide
Recruitment hospital [8] 0 0
Local Institution - Clayton Vic
Recruitment hospital [9] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst Nsw
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4102 - Woollongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Indiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Mexico
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa FE
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Brazil
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RIO Grande DO SUL
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Saskatchewan
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Denmark
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Hvidovre
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Denmark
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Odense
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France
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Clichy Cedex
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France
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Creteil Cedex
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France
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La Roche-sur-yon Cedex 9
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France
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Lille
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France
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Limoges
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France
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Lyon Cedex 04
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France
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Marseille Cedex 08
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France
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Montpellier Cedex 5
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France
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Nice Cedex 03
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France
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Paris Cedex 12
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France
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Paris Cedex 13
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France
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Paris Cedex 14
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France
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PESSAC Cedex
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France
State/province [49] 0 0
Toulouse Cedex 09
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France
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Vandoeuvre Les Nancy
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Germany
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Dusseldorf
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Mainz
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Ireland
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Dublin
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Italy
State/province [59] 0 0
Brescia
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Italy
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Cisanello (pisa)
Country [61] 0 0
Italy
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Milano
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Italy
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Pavia
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Italy
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Torino
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Italy
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Viale Del Policlinico, 155
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Japan
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Aichi
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Japan
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Chiba
Country [67] 0 0
Japan
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Fukuoka
Country [68] 0 0
Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kagawa
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Yamanashi
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Busan
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Mexico
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Jalisco
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Mexico
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Morelos
Country [86] 0 0
Mexico
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Nuevo LEON
Country [87] 0 0
Poland
State/province [87] 0 0
Bialystok
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Puerto Rico
State/province [88] 0 0
San Juan
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Spain
State/province [89] 0 0
Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santiago De Compostela
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Spain
State/province [94] 0 0
Sevilla
Country [95] 0 0
Spain
State/province [95] 0 0
Valencia
Country [96] 0 0
Sweden
State/province [96] 0 0
Gothenburg
Country [97] 0 0
Sweden
State/province [97] 0 0
Stockholm
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taichung
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Greater Manchester
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.
Trial website
https://clinicaltrials.gov/study/NCT01492504
Trial related presentations / publications
Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT01492504