A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663208

AI444-004

Details and patient eligibility

About

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Enrollment: 167 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronically infected with Hepatitis C Virus (HCV) genotype 1
• Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus
• HCV RNA viral load of ≥10*5 IU/mL
• BMI 18 to 35kg/m²

Exclusion criteria

• Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection
• HIV and/or HBV positive
• Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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167 participants in 6 patient groups

Group 1

Active Comparator group

Description:

Daclatasvir (1 mg), once daily or Matching Placebo, once daily

Treatment:

Drug: Placebo

Drug: Daclatasvir

Group 2

Active Comparator group

Description:

Daclatasvir (10 mg), once daily or Matching Placebo, once daily

Treatment:

Drug: Placebo

Drug: Daclatasvir

Group 3

Active Comparator group

Description:

Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily

Treatment:

Drug: Placebo

Drug: Daclatasvir

Group 4

Active Comparator group

Description:

Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily

Treatment:

Drug: Placebo

Drug: Daclatasvir

Group 5

Active Comparator group

Description:

Group 5: Active Comparator Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily

Treatment:

Drug: Placebo

Drug: Daclatasvir

Group 6

Active Comparator group

Description:

Group 6: Active Comparator Daclatasvir (1-100 mg), once or twice daily or Matching Placebo, once or twice daily

Treatment:

Drug: Placebo

Drug: Daclatasvir