Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01257204
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Placebo Drug: Daclatasvir Drug: Pegylated interferon alfa-2a Drug: Ribavirin Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control
Placebo + Pegylated interferon alfa-2a + Ribavirin
 Drug: Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks

Drug: Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Other Name: Pegasys®

Drug: Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Other Name: Copegus®
Experimental: 12 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
 Drug: Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Other Name: BMS-790052

Drug: Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Other Name: Pegasys®

Drug: Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Other Name: Copegus®
Experimental: 16 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
 Drug: Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Other Name: BMS-790052

Drug: Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Other Name: Pegasys®

Drug: Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Other Name: Copegus®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2 [ Time Frame: Follow-up Week 24 ]
    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.

  2. Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3 [ Time Frame: Follow-up Week 24 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2 [ Time Frame: Week 4 ]
    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.

  2. Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3 [ Time Frame: Week 4 ]
    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.

  3. Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2 [ Time Frame: Week 12 ]
    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.

  4. Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3 [ Time Frame: Week 12 ]
    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.

  5. Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2 [ Time Frame: Follow-up Week 12 ]
    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.

  6. Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3 [ Time Frame: Follow-up Week 12 ]
    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.

  7. Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2 [ Time Frame: Baseline up to Week 48 ]

    Virologic failure was defined as:

    1. 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
    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 or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
    5. 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.


  8. Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3 [ Time Frame: Baseline up to Week 48 ]

    Virologic failure was defined as:

    1. 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
    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 or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
    5. 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.


  9. 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 [ Time Frame: Baseline (Day 1) up to 24 weeks (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.

  10. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period [ Time Frame: From end of treatment period up to Week 48 (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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257204


Locations
Layout table for location information
United States, California
California Liver Institute
Los Angeles, California, United States, 90048
United States, Maryland
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
United States, Oklahoma
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
Australia, New South Wales
Local Institution
Darlinghurst, New South Wales, Australia, 2010
Local Institution
Westmead Nsw, New South Wales, Australia, 2145
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Clayton Vic, Victoria, Australia, 3168
Australia, Western Australia
Local Institution
Fremantle, Western Australia, Australia, 6160
Australia
Local Institution
Camperdown, Australia, NSW 2050
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2N2
Denmark
Local Institution
Hvidovre, Denmark, 2650
France
Local Institution
Creteil, France, 94000
Local Institution
Lille Cedex, France, 59037
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Nice Cedex 03, France, 06202
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Pessac, France, 33604
Italy
Local Institution
Brescia, Italy, 25123
Local Institution
Cisanello (pisa), Italy, 56124
Local Institution
Viale Del Policlinico, 155, Italy, 00161
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01257204    
Other Study ID Numbers: AI444-031
2010-022408-28 ( EudraCT Number )
First Posted: December 9, 2010    Key Record Dates
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs