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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01125189




Registration number
NCT01125189
Ethics application status
Date submitted
17/05/2010
Date registered
18/05/2010
Date last updated
23/10/2015

Titles & IDs
Public title
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Scientific title
A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
Secondary ID [1] 0 0
2010-018295-24
Secondary ID [2] 0 0
AI444-010
Universal Trial Number (UTN)
Trial acronym
HEPCAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 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 - Daclatasvir
Treatment: Drugs - Placebo
Treatment: Drugs - peg-interferon alfa-2a
Treatment: Drugs - ribavirin

Experimental: Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg) -

Experimental: Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg) -

Placebo comparator: Placebo plus peg-interferon alfa-2a and ribavirin -


Treatment: Drugs: Daclatasvir
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response

Treatment: Drugs: Daclatasvir
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response

Treatment: Drugs: Placebo
Tablets, oral, 0 mg, once daily, 24 weeks

Treatment: Drugs: peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response

Treatment: Drugs: ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
Timepoint [1] 0 0
Weeks 4 and 12
Primary outcome [2] 0 0
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
Timepoint [2] 0 0
Follow-up Week 24
Primary outcome [3] 0 0
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
Timepoint [3] 0 0
From start of study treatment (day 1) up to follow-up Week 48
Secondary outcome [1] 0 0
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
Timepoint [3] 0 0
Follow-up Week 12
Secondary outcome [4] 0 0
Percentage of Resistant Variants Associated With Virologic Failure
Timepoint [4] 0 0
Follow-up Week 48

Eligibility
Key inclusion criteria
* Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
* HCV RNA viral load of =100,000 IU/mL
* No previous exposure to interferon, pegIFNa, or RBV
* Results of a liver biopsy demonstrating absence of cirrhosis obtained =24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
* Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
* Body mass index of 18 to 35 kg/m^2
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
* Evidence of a medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
558
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [3] 0 0
Local Institution - Woolloongabba
Recruitment hospital [4] 0 0
Local Institution - Adelaide
Recruitment hospital [5] 0 0
Local Institution - Clayton Vic
Recruitment hospital [6] 0 0
Local Institution - Camperdown
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [6] 0 0
NSW 2050 - Camperdown
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
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Denmark
State/province [22] 0 0
Aarhus
Country [23] 0 0
Denmark
State/province [23] 0 0
Hvidovre
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense
Country [25] 0 0
Egypt
State/province [25] 0 0
Menoufiya
Country [26] 0 0
Egypt
State/province [26] 0 0
Cairo
Country [27] 0 0
France
State/province [27] 0 0
Creteil
Country [28] 0 0
France
State/province [28] 0 0
Marseille Cedex 08
Country [29] 0 0
France
State/province [29] 0 0
Montpellier Cedex 5
Country [30] 0 0
France
State/province [30] 0 0
Paris Cedex 12
Country [31] 0 0
France
State/province [31] 0 0
Paris Cedex 14
Country [32] 0 0
Germany
State/province [32] 0 0
Duesseldorf
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Italy
State/province [36] 0 0
Cisanello (pisa)
Country [37] 0 0
Italy
State/province [37] 0 0
Pavia
Country [38] 0 0
Mexico
State/province [38] 0 0
Jalisco
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
San Juan
Country [40] 0 0
Sweden
State/province [40] 0 0
Gothenburg
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm

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/NCT01125189