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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/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
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Florida
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United States of America
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Georgia
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Illinois
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Indiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Mexico
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New York
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United States of America
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North Carolina
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United States of America
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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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United States of America
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Virginia
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Washington
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United States of America
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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
State/province [30] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Saskatchewan
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Denmark
State/province [34] 0 0
Hvidovre
Country [35] 0 0
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
State/province [38] 0 0
La Roche-sur-yon Cedex 9
Country [39] 0 0
France
State/province [39] 0 0
Lille
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France
State/province [40] 0 0
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
State/province [44] 0 0
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
Country [47] 0 0
France
State/province [47] 0 0
Paris Cedex 14
Country [48] 0 0
France
State/province [48] 0 0
PESSAC Cedex
Country [49] 0 0
France
State/province [49] 0 0
Toulouse Cedex 09
Country [50] 0 0
France
State/province [50] 0 0
Vandoeuvre Les Nancy
Country [51] 0 0
Germany
State/province [51] 0 0
Dusseldorf
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Germany
State/province [52] 0 0
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
State/province [57] 0 0
Mainz
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Ireland
State/province [58] 0 0
Dublin
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Italy
State/province [59] 0 0
Brescia
Country [60] 0 0
Italy
State/province [60] 0 0
Cisanello (pisa)
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
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Italy
State/province [62] 0 0
Pavia
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Italy
State/province [63] 0 0
Torino
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Italy
State/province [64] 0 0
Viale Del Policlinico, 155
Country [65] 0 0
Japan
State/province [65] 0 0
Aichi
Country [66] 0 0
Japan
State/province [66] 0 0
Chiba
Country [67] 0 0
Japan
State/province [67] 0 0
Fukuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Gifu
Country [69] 0 0
Japan
State/province [69] 0 0
Hiroshima
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Japan
State/province [70] 0 0
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
State/province [81] 0 0
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
Country [94] 0 0
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/ct2/show/NCT01492504
Trial related presentations / publications
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/ct2/show/NCT01492504