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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
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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:
1. 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
2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment
4. HCV RNA \< LLOQ, TD or = LLOQ at Week 12 and = LLOQ at Week 24
5. HCV RNA =LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
6. 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
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Maximum age
70
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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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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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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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Texas
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Wisconsin
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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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Odense
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Egypt
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Menoufiya
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Egypt
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Cairo
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Creteil
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Marseille Cedex 08
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Montpellier Cedex 5
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Paris Cedex 12
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France
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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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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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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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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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Country
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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/study/NCT01125189
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Trial related presentations / publications
Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.
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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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Fax
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Email
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Contact person for public queries
Name
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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/NCT01125189
Download to PDF