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. - ND

Bristol-Myers Squibb International Corporation0 sites210 target enrollmentNovember 30, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Bristol-Myers Squibb International Corporation
Enrollment: 210
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 30, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb International Corporation

Eligibility Criteria

Inclusion Criteria

•1\) Signed Written Informed Consent 2\) Target Population a) Subjects chronically infected with either HCV genotype 2 or 3 (each HCV genotype will be capped at approximately 50% of the randomized study population), as documented by positive HCV RNA and anti\-HCV antibody at screening and either: i) positive anti\-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening; or ii) liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation); b) No previous exposure to an interferon formulation (ie IFNa, pegIFNa) or RBV; c) HCV RNA viral load of \= 100,000 IU/mL at screening; d) Results of liver biopsy obtained \= 24 months prior to randomization demonstrating the presence or absence of cirrhosis; for compensated cirrhotics, results of liver biopsy documenting cirrhosis can be from any time period prior to randomization (compensated cirrhotics are capped at approximately 10% of randomized population); e) Body Mass Index (BMI) of 18 to 35 kg/m?, inclusive. BMI \= weight (kg)/\[height (m)]? at screening. 3\) Age and Reproductive Status Males and female, 18 \- 70 years of age; a) Contraception requirements for women who are WOCBP (see Section 3\.3\.3\) and men who are sexually active with WOCBP: i) Two (2\) separate forms of contraception are required from time of screening, throughout the duration of the on\-treatment study period, and for at least 24 weeks after the last dose of RBV (or the duration specified by the country\-specific RBV label, whichever is longer) in such a manner that pregnancy is minimized. One (1\) form of contraception must be an effective barrier method (eg, condom, diaphragm, cervical cap). Oral contraceptive pills (OCPs) may be used in this study as 1 of the 2 effective forms of contraception based on results of a drug interaction study with BMS\-790052 and Ortho Tri\-Cyclen. Following co\-administration of 60 mg BMS\-790052 and Ortho Tri\-Cyclen for 10 days, no pharmacokinetic interaction was observed; therefore, co\-administration of BMS\-790052 and an OCP should not alter the efficacy of the OCP.
•For further details, see the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\)Target Disease Exceptions a)Infected with HCV other than genotype 2 or 3; 2\)Medical History \& Concurrent Diseases a)Liver transplant recipients; b)Documented or suspected HCC as evidence by imaging or liver biopsy; c)Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria; d)Evidence of medical condition associated with chronic liver disease other than HCV; e)History of chronic HBV as documented by HBV serologies. Patients with resolved HBV infection may participate; f)Current or known history of cancer within 5 years prior to enrollment; g)Any gastrointestinal disease or surgical procedure that may impact study drug absorption; h)Any other medical, psychiatric and/or social reason including active substance abuse as defined by DSM\-IV (Appendix 1\), which in the opinion of the investigator, would make the candidate inappropriate for participation; i)Inability to tolerate oral medication; j)Poor venous access; \+ exclusion criteria for the use of pegIFNa\-2a and/or RBV, based on their respective labels: k)Severe psychiatric disease, especially untreated or unstable depression, that would prohibit use of pegIFNa\-2a, as judged by the investigator; l)History of hemoglobinopathies, diagnoses associated with an increased baseline risk for anemia, hemolytic anemia, or diseases in which anemia would be medically problematic; m)Thyroid\-stimulating hormone (TSH) \< 0\.8 x LLN or \> 1\.2 x ULN of the lab reference range, unless i)The subject is clinically euthyroid as determined by the investigator, AND ii)free T4 is \= 0\.8 x LLN and \= 1\.2 x ULN n)History of chronic pulmonary disease associated with functional limitation; o)History of cardiomyopathy, coronary artery disease, interventive procedure for coronary artery disease, ventricular arrhythmia, or other clinically significant cardiac disease; p)Historical or current ECG findings indicative of cardiovascular instability; q)Pre\-existing ophthalmologic disorders considered clinically significant on eye; r)History of uncontrolled diabetes mellitus; s)Any known contraindication to pegIFNa\-2a or RBV, not otherwise specified. 3\)Physical \& Lab Test Findings.
•For further details, see the protocol.