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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01428063




Registration number
NCT01428063
Ethics application status
Date submitted
1/09/2011
Date registered
2/09/2011
Date last updated
27/05/2016

Titles & IDs
Public title
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Scientific title
An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
Secondary ID [1] 0 0
2011-000836-27
Secondary ID [2] 0 0
AI444-026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection 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
Interventional
Description of intervention(s) / exposure
Experimental: Daclatasvir + Asunaprevir + PegIFNa-2a + Ribavirin - Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNa-2a, 180-µg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks

Experimental: Daclatasvir + PegIFNa-2a + Ribavirin - Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNa-2a, 180-µg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks

Experimental: Daclatasvir + Asunaprevir - Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
Timepoint [1] 0 0
Week 12 (Follow-up period)
Secondary outcome [1] 0 0
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Timepoint [1] 0 0
Week 12 (Follow-up period)
Secondary outcome [2] 0 0
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Timepoint [3] 0 0
Week 4 and 12
Secondary outcome [4] 0 0
Percentage of Participants With Complete Early Virologic Response (cEVR)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With End of the Treatment Response (EOTR)
Timepoint [5] 0 0
End of the study (Week 24)
Secondary outcome [6] 0 0
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Timepoint [6] 0 0
Week 24 (Follow-up)
Secondary outcome [7] 0 0
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
Timepoint [7] 0 0
For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation

Eligibility
Key inclusion criteria
Key

* Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNa-2a/ribavirin + placebo) during the trial
* Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
* HCV RNA viral load detectable

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Discontinuation from a prior BMS HCV clinical trial due to a pegIFNa-2a/ribavirin-related event
* Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
* Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
* Evidence of medical condition associated with chronic liver disease other than HCV infection
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 2
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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Kogarah
Recruitment hospital [3] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [4] 0 0
Local Institution - Adelaide
Recruitment hospital [5] 0 0
Local Institution - Clayton Vic
Recruitment hospital [6] 0 0
Local Institution - Fitzroy
Recruitment hospital [7] 0 0
Local Institution - Heidelberg
Recruitment hospital [8] 0 0
Local Institution - Melbourne
Recruitment hospital [9] 0 0
Local Institution - Fremantle
Recruitment hospital [10] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2218 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [6] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6160 - Fremantle
Recruitment postcode(s) [10] 0 0
6001 - Perth
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
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Austria
State/province [19] 0 0
Graz
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Denmark
State/province [24] 0 0
Hvidovre
Country [25] 0 0
France
State/province [25] 0 0
Bondy Cedex
Country [26] 0 0
France
State/province [26] 0 0
Clichy Cedex
Country [27] 0 0
France
State/province [27] 0 0
Creteil
Country [28] 0 0
France
State/province [28] 0 0
Lille
Country [29] 0 0
France
State/province [29] 0 0
Lyon Cedex 02
Country [30] 0 0
France
State/province [30] 0 0
Marseille Cedex 08
Country [31] 0 0
France
State/province [31] 0 0
Montpellier Cedex 5
Country [32] 0 0
France
State/province [32] 0 0
Nice Cedex 03
Country [33] 0 0
France
State/province [33] 0 0
Paris Cedex 12
Country [34] 0 0
France
State/province [34] 0 0
Paris Cedex 13
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 14
Country [36] 0 0
France
State/province [36] 0 0
Toulouse Cedex 09
Country [37] 0 0
France
State/province [37] 0 0
Toulouse
Country [38] 0 0
France
State/province [38] 0 0
Vandoeuvre Cedex
Country [39] 0 0
France
State/province [39] 0 0
Villejuif Cedex
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Bonn
Country [42] 0 0
Germany
State/province [42] 0 0
Frankfurt
Country [43] 0 0
Germany
State/province [43] 0 0
Hamburg
Country [44] 0 0
Germany
State/province [44] 0 0
Hannover
Country [45] 0 0
Germany
State/province [45] 0 0
Heidelberg
Country [46] 0 0
Greece
State/province [46] 0 0
Thesaloniki
Country [47] 0 0
Ireland
State/province [47] 0 0
Dublin
Country [48] 0 0
Italy
State/province [48] 0 0
Brescia
Country [49] 0 0
Italy
State/province [49] 0 0
Cisanello (pisa)
Country [50] 0 0
Italy
State/province [50] 0 0
Messina
Country [51] 0 0
Italy
State/province [51] 0 0
Milano
Country [52] 0 0
Italy
State/province [52] 0 0
Pavia
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Italy
State/province [54] 0 0
Torino
Country [55] 0 0
Italy
State/province [55] 0 0
Viale Del Policlinico, 155
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Busan
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Daegu
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Gyeonggi-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Mexico
State/province [60] 0 0
Jalisco
Country [61] 0 0
New Zealand
State/province [61] 0 0
Auckland
Country [62] 0 0
Poland
State/province [62] 0 0
Bialystok
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Sweden
State/province [65] 0 0
Gothenburg
Country [66] 0 0
Sweden
State/province [66] 0 0
Stockholm
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taichung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taipei
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Greater London
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Greater Manchester
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Lanarkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01428063