Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

Hepatitis C Infection Clinical Trial

Official title:

A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017575
• Other study ID #: AI444-022
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2009
• Last updated: August 13, 2015
• Start date: December 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Subjects chronically infected with hepatitis C virus (HCV) genotype 1

• HCV RNA viral load = 10*5* IU/mL (100,000 IU/mL) at screening

• The current standard of care naïve or non-responder

Key Exclusion Criteria:

• Cirrhosis

• HCC

• Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Infection

Intervention

Drug:
• Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
• Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
• Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
• Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
• Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Locations

Country	Name	City	State
Japan	Local Institution	Chiba-Shi	Chiba
Japan	Local Institution	Kurume-Shi	Fukuoka
Japan	Local Institution	Musashino-Shi	Tokyo
Japan	Local Institution	Okayama-Shi	Okayama
Japan	Local Institution	Osaka-Shi	Osaka
Japan	Local Institution	Osaka-Shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.	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.	From Baseline up to 30 days after last dose of study drug	Yes
Other	Number of Participants With Grade 3 to 4 Laboratory Abnormalities	Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (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; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.	From screening up to Week 12 (treatment period)	Yes
Primary	Percentage of Participants With Extended Rapid Virologic Response (eRVR)	eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.	From Week 4 up to Week 12	Yes
Secondary	Percentage of Participants With Rapid Virologic Response (RVR)	RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.	Week 4	No
Secondary	Percentage of Participants With a Complete Early Virologic Response (cEVR)	cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.	Week 12	No
Secondary	Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24	SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.	Follow up Week 12, Follow up Week 24	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form