Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

Hepatitis C Virus Clinical Trial

Official title:

A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257204
• Other study ID #: AI444-031
• Secondary ID: 2010-022408-28
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2010
• Last updated: November 10, 2015
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Biological and Radiopharmaceutical DrugsDenmark: LægemiddelstyrelsenFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Istituto Superiore di Sanità (ISS)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3

• No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin

• Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2

• Males and females, 18 - 70 years of age

Key Exclusion Criteria:

• Liver transplant recipients

• Documented or suspected hepatocellular carcinoma

• Evidence of decompensated cirrhosis

• History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate

• Current or known history of cancer

• Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug

• Inability to tolerate oral medication

• Poor venous access

• Severe psychiatric disease

• History of chronic pulmonary disease

• History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease

• History of or current electrocardiogram findings indicative of cardiovascular instability

• Preexisting ophthalmologic disorders considered clinically significant on eye

• History of uncontrolled diabetes mellitus

• Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.

• Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab

• Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)

• Exposure to any investigational drug or placebo

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis, Chronic

Intervention

Drug:
• Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks
• Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
• Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
• Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown
Australia	Local Institution	Clayton Vic	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Westmead Nsw	New South Wales
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
Canada	Local Institution	Winnipeg	Manitoba
Denmark	Local Institution	Hvidovre
France	Local Institution	Creteil
France	Local Institution	Lille Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nice Cedex 03
France	Local Institution	Paris Cedex 14
France	Local Institution	Pessac
Italy	Local Institution	Brescia
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Viale Del Policlinico, 155
United States	Digestive Disease Associates, P.A.	Baltimore	Maryland
United States	California Liver Institute	Los Angeles	California
United States	Alamo Medical Research	San Antonio	Texas
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2	SVR24 was defined as undetectable HCV RNA (HCV RNA	Follow-up Week 24	No
Primary	Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3	SVR24 was defined as undetectable HCV RNA (HCV RNA	Follow-up Week 24	No
Secondary	Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2	RVR was defined as undetectable HCV RNA (HCV RNA	Week 4	No
Secondary	Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3	RVR was defined as undetectable HCV RNA (HCV RNA	Week 4	No
Secondary	Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2	cEVR was defined as undetectable HCV RNA (HCV RNA	Week 12	No
Secondary	Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3	cEVR was defined as undetectable HCV RNA (HCV RNA	Week 12	No
Secondary	Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2	SVR12 was defined as undetectable HCV RNA (HCV RNA	Follow-up Week 12	No
Secondary	Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3	SVR12 was defined as undetectable HCV RNA (HCV RNA	Follow-up Week 12	No
Secondary	Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2	Virologic failure was defined as: Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment; Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment; HCV RNA =LLOQ or Relapse, defined as HCV RNA =LLOQ or The LLOQ was 25 IU/mL, and	Baseline up to Week 48	No
Secondary	Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3	Virologic failure was defined as: Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment; Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment; HCV RNA =LLOQ or Relapse, defined as HCV RNA =LLOQ or The LLOQ was 25 IU/mL, and	Baseline up to Week 48	No
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period	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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.	Baseline (Day 1) up to 24 weeks (treatment period)	Yes
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period	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 end of treatment period up to Week 48 (follow-up period)	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form