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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/NCT01257204
Registration number
NCT01257204
Ethics application status
Date submitted
1/12/2010
Date registered
9/12/2010
Date last updated
14/12/2015
Titles & IDs
Public title
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
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Scientific title
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
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Secondary ID [1]
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2010-022408-28
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Secondary ID [2]
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AI444-031
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Universal Trial Number (UTN)
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Trial acronym
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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 - Placebo
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Pegylated interferon alfa-2a
Treatment: Drugs - Ribavirin
Active Comparator: Control - Placebo + Pegylated interferon alfa-2a + Ribavirin
Experimental: 12 Week Cohort - Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Experimental: 16 Week Cohort - Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Treatment: Drugs: Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks
Treatment: Drugs: Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Treatment: Drugs: Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Treatment: Drugs: Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 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 Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [1]
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SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], 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 [1]
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Follow-up Week 24
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Primary outcome [2]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [2]
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SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], 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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Secondary outcome [1]
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Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [1]
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RVR was defined as undetectable HCV 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.
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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 Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [2]
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RVR was defined as undetectable HCV 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.
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Timepoint [2]
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Week 4
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Secondary outcome [3]
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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [3]
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cEVR was defined as undetectable HCV 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.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [4]
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cEVR was defined as undetectable HCV 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.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [5]
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SVR12 was defined as undetectable HCV 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.
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Timepoint [5]
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Follow-up Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [6]
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SVR12 was defined as undetectable HCV 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.
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Timepoint [6]
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Follow-up Week 12
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Secondary outcome [7]
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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [7]
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Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in 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 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.
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Timepoint [7]
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Baseline up to Week 48
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Secondary outcome [8]
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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [8]
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Virologic failure was defined as:
Virologic breakthrough: confirmed >1 log10 increase in 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 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.
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Timepoint [8]
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Baseline up to Week 48
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Secondary outcome [9]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
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Assessment method [9]
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
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Timepoint [9]
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Baseline (Day 1) up to 24 weeks (treatment period)
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Secondary outcome [10]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
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Assessment method [10]
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. 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 [10]
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From end of treatment period up to Week 48 (follow-up period)
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Eligibility
Key inclusion criteria
Key
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated
interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- Males and females, 18 - 70 years of age
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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
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may
participate
- Current or known history of cancer
- Any gastrointestinal disease or surgical procedure that may impact the absorption of
study drug
- Inability to tolerate oral medication
- Poor venous access
- Severe psychiatric disease
- History of chronic pulmonary disease
- History of cardiomyopathy, coronary artery disease (including angina), interventive
procedure for coronary artery disease (including angioplasty, stent procedure, or
cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant
cardiac disease
- History of or current electrocardiogram findings indicative of cardiovascular
instability
- Preexisting ophthalmologic disorders considered clinically significant on eye
- History of uncontrolled diabetes mellitus
- Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise
specified.
- Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
- Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase,
previous nonstructural protein 5A inhibitors)
- Exposure to any investigational drug or placebo
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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
1/12/2010
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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
1/09/2012
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Sample size
Target
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Accrual to date
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Final
196
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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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 - Adelaide
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Recruitment hospital [4]
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Local Institution - Clayton Vic
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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 - 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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5000 - Adelaide
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Recruitment postcode(s) [4]
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3168 - Clayton Vic
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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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NSW 2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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United States of America
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State/province [3]
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Oklahoma
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
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Canada
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State/province [6]
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British Columbia
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Country [7]
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Canada
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State/province [7]
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Manitoba
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Denmark
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State/province [9]
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Hvidovre
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Country [10]
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France
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State/province [10]
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Creteil
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Country [11]
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France
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State/province [11]
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Lille Cedex
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Country [12]
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France
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State/province [12]
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Montpellier Cedex 5
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Country [13]
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France
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State/province [13]
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Nice Cedex 03
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Country [14]
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France
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State/province [14]
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Paris Cedex 14
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Country [15]
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France
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State/province [15]
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Pessac
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Country [16]
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Italy
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State/province [16]
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Brescia
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Country [17]
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Italy
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State/province [17]
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Cisanello (pisa)
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Country [18]
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Italy
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State/province [18]
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Viale Del Policlinico, 155
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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 identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of
daclatasvir with pegylated interferon alfa-2a and ribavirin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01257204
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01257204
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