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Completed

NCT Number: NCT01017575

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

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

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daclatasvir

Drug

Tablets, Oral, 10 mg, daily, 24-48 weeks

Placebo

Drug

Tablets, Oral, 0 mg, daily, 48 weeks

Peginterferon alfa-2a

Drug

Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks

Other names: Pegasys®

Ribavirin

Drug

Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Other names: Copegus®

Primary outcomes

  1. Percentage of Participants With Extended Rapid Virologic Response (eRVR)

    Time frame: From Week 4 up to Week 12

    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.

Secondary outcomes

  1. Percentage of Participants With Rapid Virologic Response (RVR)

    Time frame: Week 4

    RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.

  2. Percentage of Participants With a Complete Early Virologic Response (cEVR)

    Time frame: Week 12

    cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.

  3. Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24

    Time frame: Follow up Week 12, 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.

Other outcomes

  1. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.

    Time frame: From Baseline up to 30 days after last dose of study drug

    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.

  2. Number of Participants With Grade 3 to 4 Laboratory Abnormalities

    Time frame: From screening up to Week 12 (treatment period)

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2009
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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