Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01428063
Ethics application status
Date submitted
1/09/2011
Date registered
1/09/2011
Date last updated
21/04/2016

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
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Asunaprevir
Treatment: Drugs - Pegylated interferon alfa-2a
Treatment: Drugs - Ribavirin

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


Treatment: Drugs: Daclatasvir


Treatment: Drugs: Asunaprevir


Treatment: Drugs: Pegylated interferon alfa-2a


Treatment: Drugs: Ribavirin


Intervention code [1] 0 0
Treatment: Drugs
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) - SVR12 defined as HCV RNA
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) - SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
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 - RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.
Timepoint [3] 0 0
Week 4 and 12
Secondary outcome [4] 0 0
Percentage of Participants With Complete Early Virologic Response (cEVR) - cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With End of the Treatment Response (EOTR) - EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.
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) - SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
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 - AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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
Gender
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
Blinded (masking 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
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,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
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United States of America
State/province [2] 0 0
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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Maryland
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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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New York
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North Carolina
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Oklahoma
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Pennsylvania
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Tennessee
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United States of America
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Texas
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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
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Austria
State/province [20] 0 0
Wien
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Canada
State/province [21] 0 0
British Columbia
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Canada
State/province [22] 0 0
Ontario
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Canada
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Quebec
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Denmark
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Hvidovre
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France
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Bondy Cedex
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France
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Clichy Cedex
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France
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Creteil
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France
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Lille
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France
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Lyon Cedex 02
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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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Toulouse Cedex 09
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France
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Toulouse
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France
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Vandoeuvre Cedex
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Bonn
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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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Greece
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Thesaloniki
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Ireland
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Dublin
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Italy
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Brescia
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Italy
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Cisanello (pisa)
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Italy
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Messina
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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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Roma
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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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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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New Zealand
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Auckland
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Poland
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Bialystok
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Poland
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Wroclaw
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Spain
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Barcelona
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Sweden
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Gothenburg
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Sweden
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Stockholm
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
State/province [69] 0 0
Greater London
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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
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received
placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and
determine whether addition of these drugs results in higher cure rates in patients who
previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS
study NCT01428063 (AI447-028) will receive active drugs in this study.
Trial website
https://clinicaltrials.gov/show/NCT01428063
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