The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa FE
Country [27] 0 0
Brazil
State/province [27] 0 0
RIO Grande DO SUL
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio De Janeiro
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatchewan
Country [34] 0 0
Denmark
State/province [34] 0 0
Hvidovre
Country [35] 0 0
Denmark
State/province [35] 0 0
Odense
Country [36] 0 0
France
State/province [36] 0 0
Clichy Cedex
Country [37] 0 0
France
State/province [37] 0 0
Creteil Cedex
Country [38] 0 0
France
State/province [38] 0 0
La Roche-sur-yon Cedex 9
Country [39] 0 0
France
State/province [39] 0 0
Lille
Country [40] 0 0
France
State/province [40] 0 0
Limoges
Country [41] 0 0
France
State/province [41] 0 0
Lyon Cedex 04
Country [42] 0 0
France
State/province [42] 0 0
Marseille Cedex 08
Country [43] 0 0
France
State/province [43] 0 0
Montpellier Cedex 5
Country [44] 0 0
France
State/province [44] 0 0
Nice Cedex 03
Country [45] 0 0
France
State/province [45] 0 0
Paris Cedex 12
Country [46] 0 0
France
State/province [46] 0 0
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
Country [52] 0 0
Germany
State/province [52] 0 0
Essen
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt
Country [54] 0 0
Germany
State/province [54] 0 0
Hamburg
Country [55] 0 0
Germany
State/province [55] 0 0
Hannover
Country [56] 0 0
Germany
State/province [56] 0 0
Heidelberg
Country [57] 0 0
Germany
State/province [57] 0 0
Mainz
Country [58] 0 0
Ireland
State/province [58] 0 0
Dublin
Country [59] 0 0
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
Country [62] 0 0
Italy
State/province [62] 0 0
Pavia
Country [63] 0 0
Italy
State/province [63] 0 0
Torino
Country [64] 0 0
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
Country [70] 0 0
Japan
State/province [70] 0 0
Hokkaido
Country [71] 0 0
Japan
State/province [71] 0 0
Hyogo
Country [72] 0 0
Japan
State/province [72] 0 0
Ishikawa
Country [73] 0 0
Japan
State/province [73] 0 0
Kagawa
Country [74] 0 0
Japan
State/province [74] 0 0
Kagoshima
Country [75] 0 0
Japan
State/province [75] 0 0
Kanagawa
Country [76] 0 0
Japan
State/province [76] 0 0
Miyagi
Country [77] 0 0
Japan
State/province [77] 0 0
Okayama
Country [78] 0 0
Japan
State/province [78] 0 0
Osaka
Country [79] 0 0
Japan
State/province [79] 0 0
Saitama
Country [80] 0 0
Japan
State/province [80] 0 0
Tokyo
Country [81] 0 0
Japan
State/province [81] 0 0
Yamanashi
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Gyeongsangnam-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Busan
Country [84] 0 0
Mexico
State/province [84] 0 0
Jalisco
Country [85] 0 0
Mexico
State/province [85] 0 0
Morelos
Country [86] 0 0
Mexico
State/province [86] 0 0
Nuevo LEON
Country [87] 0 0
Poland
State/province [87] 0 0
Bialystok
Country [88] 0 0
Puerto Rico
State/province [88] 0 0
San Juan
Country [89] 0 0
Spain
State/province [89] 0 0
Alicante
Country [90] 0 0
Spain
State/province [90] 0 0
Barcelona
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Malaga
Country [93] 0 0
Spain
State/province [93] 0 0
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/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
Other publications