Chronic Hepatitis Hepatitis C Virus
Conditions
Interventions
Treatment: At screening, subjects will have HCV genotype confirmed and will be
assigned to a treatment regimen. Approximately 200 subjects who are prior
non-responders to pegIFNa-2a/RBV will be trea
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) Signed Written Informed Consent a) Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study. 2) Target Population a) Subjects must have participated in any BMS-650032, BMS-790052, or BMS-791325 clinical trial, and must have been assigned to the control arm during the trial. b) Subjects chronically infected with HCV Genotype 1, 2, 3, or 4 (mixed genotypes are not permitted); c) HCV RNA viral load detectable. 3) Age and Reproductive Status a) Men or women, >= 18 years of age; b) Contraception requirements: Men and Women of childbearing potential (WOCBP) must be using 2 separate methods of contraception throughout the study and for up to 24 weeks after the last dose of RBV (or time specified by the country-specific RBV label, whichever is longer) in such a manner that the risk of pregnancy is minimized. i) For subjects with HCV Genotypes 1 and 4: Oral contraceptive pills may be used but cannot be considered one of the two effective forms of contraception required because drug interaction studies verifying the effectiveness of OCPs when used with BMS-650032 have not been completed. ii) For Subjects with HCV Genotypes 2 and 3: One (1) form of contraception must be effective barrier method (eg. condom, diaphragm, cervical cap). Oral contraceptive pills (OCPs) may be used in this study as one of the two effective forms of contraception. Examples of highly effective birth control include: • condom with spermicide; • diaphragm and spermacide; • cervical cap and spermacide • female condom; • intrauterine devices (IUDs); This contraception requirement applies in all cases of heterosexual intercourse in which the female partner is a WOCBP, except when the male partner is vasectomized for a minimum of 6 months and with confirmed azoospermia by the investigator; c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product. Female subjects must agree to the pregnancy testing requirements of this protocol. d) Women must not be breastfeeding; e) Requirements for male subjects (based on RBV label): i) Male subjects (unless vasectomized) with female partners who are WOCBP must agree to inform their female partners of the protocol-specified contraception requirement and pregnancy testing recommendations during treatment and post-treatment and agree to adhere to these recommendations both on-treatment and during the post-dosing follow-up period; ii) Male subjects must confirm that their female sexual partners are not pregnant at the time of screening.;In addition to the Inclusion Criteria listed above, the following Inclusion Criteria apply to all rescue subjects prior to initiation of QUAD therapy: f) Genotype 1b subjects receiving ASV+DCV only, AND g) Subjects meeting the definition of virologic breakthrough or treatment futility, AND h) HCV RNA
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Target Disease Exceptions a) Discontinuation from prior BMS HCV clinical trial due to a pegIFNa/ RBV-related event; b) Positive for HBsAg, or HIV-1/HIV-2 antibody at screening. 2) Medical History and Concurrent Diseases a) Liver transplant recipients; b) Documented or suspected HCC as evidenced by imaging or liver biopsy; c) Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria; d) Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, and toxin exposure); e) History of chronic hepatitis B virus (HBV) as documented by HBV serology (eg, (HBsAg-seropositive). Subjects with resolved HBV infection may participate (eg, HBsAb-seropositive); f) Current of known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment; g) Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug. (Subjects who have had cholecystectomy are permitted enter the study); h) Any other medical, psychiatric and/or social reason including active substance abuse as defined by DSM-IV, Diagnostic Criteria for Drug and Alcohol abuse (Appendix 1) , which in the opinion of the investigator, would make the candidate inappropriate for participation in this study; i) Inability to tolerate oral medication; j) Poor venous access; Note: The following conditions are 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 (eg. thalassemia major or sickle cell anemia), diagnoses associated with an increased baseline risk for anemia (eg, spherocytosis), hemolytic anemia, or diseases in which anemia would be medically problematic; m) History of chronic pulmonary disease associated with functional limitation; n) History of cardiopmyopathy, coronary artery disease (including angina), interventional procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia, or other clinically significant cardiac disease; o) Historical or current ECG findings indicative of cardiovascular instability, including but not limited to evidence of myocardial ischemia, unstable re-entry phenomena, other significant dysarrhythmias and/or uncontrolled hypertension; p) Pre-existing ophthalmologic disorders considered clinically significant on eye, including retinal, examination. Note: all subjects with a history of diabetes or hypertension must have a documented eye exam within 12 months prior to treatment; q) History of uncontrolled diabetes mellitus; r) Any known contraindication to pegIFNa-2a or RBV, not otherwise specified. 3) Physical and Laboratory Test Findings a) Confirmed ANC = 1.7; e) Confirmed Albumin < 3.5 g/dL (35 g/L); f) Confirmed Creatinine Clearance (CrCl) <= 50 mL/min (as estimated by Cockcroft and Gault); g) Total bi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with SVR12, defined as HCV RNA | — |
Secondary
| Measure | Time frame |
|---|---|
| •Proportion of subjects with SVR12, defined as HCV RNA | — |
Countries
Netherlands
Outcome results
None listed