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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
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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
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Secondary ID [1]
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2010-019378-34
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Secondary ID [2]
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AI444-011
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Universal Trial Number (UTN)
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Trial acronym
HEPCAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Extended Rapid Virologic Response (eRVR)
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Assessment method [1]
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eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [1]
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Week 4, Week 12
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Primary outcome [2]
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Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
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Assessment method [2]
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SVR24 was defined as undetectable RNA (Hepatitis C Virus \[HCV\] RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [2]
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Follow-up Week 24
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Primary outcome [3]
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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
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Assessment method [3]
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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. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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Timepoint [3]
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From first dose to last dose plus 7 days, up to 49 weeks
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Primary outcome [4]
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Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
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Assessment method [4]
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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. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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Timepoint [4]
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From day 8 post last dose of treatment up-to Week 72
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Secondary outcome [1]
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Percentage of Participants With Rapid Virologic Response (RVR)
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Assessment method [1]
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RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation \[LLOQ\], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants With Complete Early Virologic Response (cEVR)
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Assessment method [2]
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cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation \[LLOQ\], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
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Assessment method [3]
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SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \<lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [3]
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Follow-up Week 12
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Secondary outcome [4]
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Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
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Assessment method [4]
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Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
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Timepoint [4]
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Baseline to follow-up Week 48
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Secondary outcome [5]
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Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
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Assessment method [5]
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Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
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Timepoint [5]
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Baseline to follow-up Week 48
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2012
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Sample size
Target
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Accrual to date
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Final
512
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Local Institution - Randwick
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Recruitment hospital [2]
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Local Institution - Clayton
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Recruitment hospital [3]
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Local Institution - Heidelberg
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Recruitment hospital [4]
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Local Institution - Prahan
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Recruitment hospital [5]
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Local Institution - Fremantle
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Recruitment hospital [6]
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Local Institution - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3004 - Prahan
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Recruitment postcode(s) [5]
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6160 - Fremantle
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Recruitment postcode(s) [6]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Florida
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Indiana
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Gothenburg
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01170962
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for public queries
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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/NCT01170962
Download to PDF