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

NCT00663208 | Completed Phase 2 Results

• 1 other identifier: AI444-004
• Study Type: interventional
• Target: 167
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants

  The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.

  Baseline, Day 7

Secondary Outcomes (21)

• Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance

  Baseline, Day 7

• Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance

  Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1

• Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance

  Baseline to Day 4

• Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance

  Baseline to Day 14

• Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance

  Day 1 up to Day 14

Study Arms (6)

Group 1

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Group 2

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Group 3

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Group 4

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Group 5

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Group 6

ACTIVE COMPARATOR

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

Drug: Daclatasvir; Drug: Placebo

Interventions

Daclatasvir DRUG

Capsule, Oral, Approximately 182 days from initial dosing

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Placebo DRUG

Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Advanced Clinical Res Inst

Anaheim, California, 92801, United States

Location

West Coast Clinical Trials, Llc

Cypress, California, 90630, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Parexel International Corporation

Baltimore, Maryland, 21225, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Local Institution

Santurce, 00909, Puerto Rico

Location

Related Publications (1)

• Nettles RE, Gao M, Bifano M, Chung E, Persson A, Marbury TC, Goldwater R, DeMicco MP, Rodriguez-Torres M, Vutikullird A, Fuentes E, Lawitz E, Lopez-Talavera JC, Grasela DM. Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology. 2011 Dec;54(6):1956-65. doi: 10.1002/hep.24609.

  PMID: 21837752 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

daclatasvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 14, 2015
• Results First Posted: October 14, 2015

Record last verified: 2015-09

Locations

US (7); PR (1)