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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2010-018295-24
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Secondary ID [2]
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AI444-010
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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 - 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
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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 Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
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Assessment method [1]
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eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
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Timepoint [1]
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Weeks 4 and 12
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Primary outcome [2]
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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
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Assessment method [2]
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SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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
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Assessment method [3]
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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.
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Timepoint [3]
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From start of study treatment (day 1) up to follow-up Week 48
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Secondary outcome [1]
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Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
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Assessment method [1]
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RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
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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 Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
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Assessment method [2]
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cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
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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 Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
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Assessment method [3]
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SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
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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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Percentage of Resistant Variants Associated With Virologic Failure
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Assessment method [4]
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Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment
HCV RNA < LLOQ, TD or = LLOQ at Week 12 and = LLOQ at Week 24
HCV RNA =LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
Relapse, defined as HCV RNA =LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
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Timepoint [4]
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Follow-up Week 48
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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
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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 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
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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 assessing the outcomes
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
1/07/2010
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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
1/08/2012
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Sample size
Target
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Accrual to date
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Final
558
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - Darlinghurst
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Recruitment hospital [2]
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Local Institution - Westmead Nsw
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Recruitment hospital [3]
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Local Institution - Woolloongabba
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Recruitment hospital [4]
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Local Institution - Adelaide
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Recruitment hospital [5]
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Local Institution - Clayton Vic
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Recruitment hospital [6]
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Local Institution - Camperdown
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2145 - Westmead Nsw
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton Vic
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Recruitment postcode(s) [6]
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NSW 2050 - Camperdown
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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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United States of America
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Colorado
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Connecticut
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Florida
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United States of America
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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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North Carolina
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Oklahoma
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Canada
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Ontario
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Egypt
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Montpellier Cedex 5
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Paris Cedex 12
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Paris Cedex 14
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Germany
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Duesseldorf
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Pavia
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Jalisco
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Gothenburg
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Sweden
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State/province [41]
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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
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated
interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
virologic response rates at least 35% greater than those with placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01125189
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01125189
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