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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2010-022408-28
Secondary ID [2] 0 0
AI444-031
Universal Trial Number (UTN)
Trial acronym
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 - 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 - 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.
Timepoint [1] 0 0
Follow-up Week 24
Primary outcome [2] 0 0
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3 - 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.
Timepoint [2] 0 0
Follow-up Week 24
Secondary outcome [1] 0 0
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2 - 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.
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3 - 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.
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2 - 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.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3 - 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.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2 - 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.
Timepoint [5] 0 0
Follow-up Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3 - 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.
Timepoint [6] 0 0
Follow-up Week 12
Secondary outcome [7] 0 0
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2 - 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.
Timepoint [7] 0 0
Baseline up to Week 48
Secondary outcome [8] 0 0
Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3 - 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.
Timepoint [8] 0 0
Baseline up to Week 48
Secondary outcome [9] 0 0
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 - 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.
Timepoint [9] 0 0
Baseline (Day 1) up to 24 weeks (treatment period)
Secondary outcome [10] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period - 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.
Timepoint [10] 0 0
From end of treatment period up to Week 48 (follow-up period)

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

Key
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Clayton Vic
Recruitment hospital [5] 0 0
Local Institution - Fremantle
Recruitment hospital [6] 0 0
Local Institution - Camperdown
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment postcode(s) [6] 0 0
NSW 2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Manitoba
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Denmark
State/province [9] 0 0
Hvidovre
Country [10] 0 0
France
State/province [10] 0 0
Creteil
Country [11] 0 0
France
State/province [11] 0 0
Lille Cedex
Country [12] 0 0
France
State/province [12] 0 0
Montpellier Cedex 5
Country [13] 0 0
France
State/province [13] 0 0
Nice Cedex 03
Country [14] 0 0
France
State/province [14] 0 0
Paris Cedex 14
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
Italy
State/province [16] 0 0
Brescia
Country [17] 0 0
Italy
State/province [17] 0 0
Cisanello (pisa)
Country [18] 0 0
Italy
State/province [18] 0 0
Viale Del Policlinico, 155

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01257204
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
Other publications