Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00874770
First received: April 2, 2009
Last updated: September 23, 2015
Last verified: September 2015
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Purpose
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Infection |
Drug: Daclatasvir Drug: Placebo Drug: Peginterferon alpha-2a Drug: ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 [ Time Frame: A Weeks 4 and 12 ] [ Designated as safety issue: Yes ]eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Secondary Outcome Measures:
- Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
- Percentage of Participants With Early Virologic Response (EVR) at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.
- Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
Other Outcome Measures:
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase [ Time Frame: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug ] [ Designated as safety issue: Yes ]An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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.
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period [ Time Frame: From Day 31 up to Week 24 of post treatment follow-up ] [ Designated as safety issue: Yes ]An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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.
- Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results [ Time Frame: From screening up to Week 12 (treatment period) ] [ Designated as safety issue: Yes ]Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.
| Enrollment: | 74 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
|
Drug: Daclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
|
|
Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
|
Drug: Daclatasvir
Tablets, oral, 10 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
|
|
Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
|
Drug: Daclatasvir
Tablets, oral, 60 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
|
| Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D) |
Drug: Placebo
Tablet, oral, 0 mg, Daily 48 weeks
Drug: Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening
- Treatment naive
Key Exclusion Criteria:
- Women of child-bearing potential
- Cirrhosis
- Coinfection with HIV or hepatitis B virus
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874770
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874770
Locations
| United States, Alabama | |
| Alabama Liver & Digestive Specialists (Alds) | |
| Montgomery, Alabama, United States, 36116 | |
| United States, Colorado | |
| University Of Colorado Denver & Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale University School Of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Maryland | |
| Mercy Medical Center | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Massachusetts | |
| Llc Dba The Research Institute | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, New York | |
| Veterans Affairs Medical Center | |
| Bronx, New York, United States, 10468 | |
| United States, North Carolina | |
| Carolinas Center For Liver Disease | |
| Statesville, North Carolina, United States, 28677 | |
| United States, Oklahoma | |
| Options Health Research, Llc | |
| Tulsa, Oklahoma, United States, 74104 | |
| Healthcare Research Consultants | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Texas | |
| North Texas Research Institute | |
| Arlington, Texas, United States, 76012 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| France | |
| Local Institution | |
| Creteil, France, 94010 | |
| Local Institution | |
| Paris Cedex 14, France, 75679 | |
| Local Institution | |
| Vandoeuvre Les Nancy, France, 54511 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00874770 History of Changes |
| Other Study ID Numbers: | AI444-014 EUDRACT# 2009-010149-29 |
| Study First Received: | April 2, 2009 |
| Results First Received: | August 6, 2015 |
| Last Updated: | September 23, 2015 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica France: Ministry of Health |
Keywords provided by Bristol-Myers Squibb:
|
Antivirals |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Ribavirin |
Peginterferon alfa-2a Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 27, 2016