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Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

Phase 2
Completed
Conditions
Hepatitis C Virus
Interventions
Registration Number
NCT01125189
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
558
Inclusion Criteria
  • Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
  • HCV RNA viral load of ≥100,000 IU/mL
  • No previous exposure to interferon, pegIFNα, or RBV
  • Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
  • Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
  • Body mass index of 18 to 35 kg/m^2
Exclusion Criteria
  • Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
  • Evidence of a medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo plus peg-interferon alfa-2a and ribavirinPlacebo-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)peg-interferon alfa-2a-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)ribavirin-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)Daclatasvir-
Placebo plus peg-interferon alfa-2a and ribavirinpeg-interferon alfa-2a-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)Daclatasvir-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)peg-interferon alfa-2a-
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)ribavirin-
Placebo plus peg-interferon alfa-2a and ribavirinribavirin-
Primary Outcome Measures
NameTimeMethod
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who DiedFrom start of study treatment (day 1) up to follow-up Week 48

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.

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)Weeks 4 and 12

eRVR was defined as HCV RNA \<lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)Follow-up Week 24

SVR24 was defined as HCV \<lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

Secondary Outcome Measures
NameTimeMethod
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)Week 4

RVR was defined as undetectable RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)Week 12

cEVR was defined as undetectable RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)Follow-up Week 12

SVR12 was defined as undetectable RNA (HCV RNA \< lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Percentage of Resistant Variants Associated With Virologic FailureFollow-up Week 48

Virologic failure was defined as:

1. Virologic breakthrough: confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment

2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment

3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment

4. HCV RNA \< LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24

5. HCV RNA ≥LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)

6. Relapse, defined as HCV RNA ≥LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \< LLOQ, TND at EOT.

The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Trial Locations

Locations (36)

Alabama Liver & Digestive Specialists (Alds)

🇺🇸

Montgomery, Alabama, United States

Scripps Clinic

🇺🇸

La Jolla, California, United States

Cli

🇺🇸

Los Angeles, California, United States

Desta Digestive Disease Medical Center

🇺🇸

San Diego, California, United States

University Of California, San Francisco/Sf General Hospital

🇺🇸

San Francisco, California, United States

California Pacific Medical Center

🇺🇸

San Francisco, California, United States

Kaiser Permanente Medical Center

🇺🇸

San Francisco, California, United States

Transplant Center And Hepatology Clinic, B-154

🇺🇸

Aurora, Colorado, United States

Yale University School Of Medicine

🇺🇸

New Haven, Connecticut, United States

University Of Florida Hepatology

🇺🇸

Gainesville, Florida, United States

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Alabama Liver & Digestive Specialists (Alds)
🇺🇸Montgomery, Alabama, United States

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