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Study in Genotype 2/3 Subjects With Chronic Hepatitis C

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus

Intervention: Placebo (Drug); BMS-790052 (Drug); BMS-790052 (Drug); Pegylated-interferon alfa 2a (Drug); Pegylated-interferon alfa 2a (Drug); Pegylated-interferon alfa 2a (Drug); Ribavirin (Drug); Ribavirin (Drug); Ribavirin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) of the combination of BMS-790052 with Pegylated-interferon alfa 2a and Ribavirin.

Clinical Details

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

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

Primary outcome: To assess antiviral activity, as determined by the proportion of subjects who achieve SVR24 for each HCV genotype, defined as undetectable HCV RNA

Secondary outcome:

To assess safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs

To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs

To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA

To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA

To assess the proportion of subjects with RVR for each HCV genotype, ie, undetectable HCV RNA

To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA

To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA

To assess the proportion of subjects with SVR12 for each HCV genotype ie, undetectable HCV RNA

Frequency of genotypic substitutions associated with virologic failure for each HCV genotype

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects chronically infected with either HCV Genotype 2 or 3

- No previous exposure to an interferon formulation (ie IFNα, pegIFNα) or RBV;

- Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/[height (m)]²

- Males and female, 18 - 70 years of age

Exclusion Criteria:

- Liver transplant recipients

- Documented or suspected HCC

- 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

- Historical or current ECG findings indicative of cardiovascular instability

- Pre-existing ophthalmologic disorders considered clinically significant on eye

- History of uncontrolled diabetes mellitus

- Any known contraindication to pegIFNα-2a or RBV, not otherwise specified.

- Positive HBsAg, HIV-1 or HIV-2 Ab

- Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase,

previous NS5A inhibitors, etc)

- Exposure to any investigational drug or placebo

Locations and Contacts

Local Institution, Camperdown NSW 2050, Australia

Local Institution, Hvidovre 2650, Denmark

Local Institution, Creteil 94000, France

Local Institution, Lille Cedex 59037, France

Local Institution, Montpellier Cedex 5 34295, France

Local Institution, Nice Cedex 03 06202, France

Local Institution, Paris Cedex 14 75679, France

Local Institution, Pessac 33604, France

Local Institution, Brescia 25123, Italy

Local Institution, Cisanello (pisa) 56124, Italy

Local Institution, Viale Del Policlinico, 155 00161, Italy

Local Institution, Calgary, Alberta T2N 4Z6, Canada

Local Institution, Edmonton, Alberta T6G 2B7, Canada

Local Institution, Vancouver, British Columbia V6Z 2K5, Canada

Local Institution, Victoria, British Columbia V8V 3P9, Canada

California Liver Institute, Los Angeles, California 90048, United States

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

Digestive Disease Associates, P.A., Baltimore, Maryland 21229, United States

Local Institution, Darlinghurst, New South Wales 2010, Australia

Local Institution, Westmead Nsw, New South Wales 2145, Australia

Options Health Research, Llc, Tulsa, Oklahoma 74104, United States

Local Institution, Toronto, Ontario M5G 2N2, Canada

Local Institution, Adelaide, South Australia 5000, Australia

Alamo Medical Research, San Antonio, Texas 78215, United States

Local Institution, Clayton Vic, Victoria 3168, Australia

Local Institution, Fremantle, Western Australia 6160, Australia

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2010
Last updated: June 24, 2013

Page last updated: August 23, 2015

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