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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01170962




Registration number
NCT01170962
Ethics application status
Date submitted
16/07/2010
Date registered
28/07/2010
Date last updated
12/10/2015

Titles & IDs
Public title
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Scientific title
A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
Secondary ID [1] 0 0
2010-019378-34
Secondary ID [2] 0 0
AI444-011
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 - BMS-790052
Treatment: Drugs - BMS-790052
Treatment: Drugs - Placebo
Treatment: Drugs - peginterferon alfa-2a
Treatment: Drugs - ribavirin

Experimental: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin - (prior null responders)

Experimental: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin - (prior null responders)

Experimental: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin - (prior partial responders)

Experimental: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin - (prior partial responders)

Experimental: Arm 5: Placebo plus peginterferon alfa-2a and ribavirin - (prior partial responders only)


Treatment: Drugs: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks

Treatment: Drugs: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks

Treatment: Drugs: Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks

Treatment: Drugs: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks

Treatment: Drugs: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Timepoint [1] 0 0
Week 4, Week 12
Primary outcome [2] 0 0
Percentage of Participants With 24-week 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 On-treatment
Timepoint [3] 0 0
From first dose to last dose plus 7 days, up to 49 weeks
Primary outcome [4] 0 0
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Timepoint [4] 0 0
From day 8 post last dose of treatment up-to Week 72
Secondary outcome [1] 0 0
Percentage of Participants With Rapid Virologic Response (RVR)
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Participants With Complete Early Virologic Response (cEVR)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Timepoint [3] 0 0
Follow-up Week 12
Secondary outcome [4] 0 0
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Timepoint [4] 0 0
Baseline to follow-up Week 48
Secondary outcome [5] 0 0
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Timepoint [5] 0 0
Baseline to follow-up Week 48

Eligibility
Key inclusion criteria
* Subjects chronically infected with HCV genotype 1
* Non-responder to prior therapy with peginterferon alfa and ribavirin
* HCV RNA viral load of 100,00 IU/mL
* Results of a liver biopsy = 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
* Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
* Body Mass Index (BMI) of 18 to 35 kg/m2
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 infection (HBsAg) or HIV-1/HIV-2 antibody at screening
* Evidence of 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 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
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
512
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Randwick
Recruitment hospital [2] 0 0
Local Institution - Clayton
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Prahan
Recruitment hospital [5] 0 0
Local Institution - Fremantle
Recruitment hospital [6] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Prahan
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 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
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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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Indiana
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United States of America
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Louisiana
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Maryland
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Massachusetts
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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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Rhode Island
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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
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Virginia
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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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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Denmark
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Aarhus
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Denmark
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Hvidovre
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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
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Lyon Cedex 04
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France
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Nice Cedex 03
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France
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Paris Cedex 14
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France
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Paris Cedex
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France
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Vandoeuvre Les Nancy
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Germany
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Essen
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Germany
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Frankfurt
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Hamburg
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Hannover
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Italy
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Cisanello (pisa)
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Italy
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Pavia
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Mexico
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Jalisco
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Mexico
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Morelos
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Mexico
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Nuevo Leon
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Sweden
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Gothenburg
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Sweden
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Stockholm

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 determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Trial website
https://clinicaltrials.gov/study/NCT01170962
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/study/NCT01170962