Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribaviri
- Conditions
- Chronic Hepatitis C Virus Infection (Genotypes 1 and 4) in Treatment-Naive SubjectsMedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2009-013652-69-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 435
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 chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and anti-HCV anti-body at the time of screening (Stages 1 and 2);
b) Subjects chronically infected with HCV genotype 4 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and anti-HCV anti-body at the time of screening (Stage 2 only);
c) HCV RNA viral load of = 100,000 IU/mL at screening;
d) Results of a biopsy obtained = 24 months prior to randomization showing no evidence of cirrhosis for subjects that do not have a diagnosis of cirrhosis (Stages 1 and 2); (Note: Genotype 1 subjects with compensated cirrhosis, regardless of time since biopsy, may be included in Stage 2);
e) Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/[height (m)]² at screening
3) Age and Sex
a) Men and women, ages 18 to 70;
b) Women of childbearing potential (WOCBP), unless non-heterosexual active or who have vasectomized male partners, and sexually active men (unless vasectomized) with female partners who are WOCBP must use two separate forms of contraception, one of which must be an effective barrier method (eg, condom with spermicide), from screening throughout the duration of the study and for 24 weeks after the last dose of ribavirin. In addition, WOCBP must agree to the pregnancy testing schedule specified in this protocol. Oral contraceptive pills (OCPs) may be used in this study, 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. Men (unless vasectomized) with female partners who are WOCBP must agree to inform their female partners of the protocol-specified contraception requirements and pregnancy testing recommendations during treatment and post-treatment (monthly pregnancy testing on-treatment and following discontinuation of RBV for 6 months post-treatment or the duration specified in
the label used for RBV in that country), and agree to adhere to these
recommendations for both the on-treatment and post-treatment follow-up period.
WOCBP are defined as a non-menopausal female or a female with menopause = 2 years and who has not had a hysterectomy, bilateral tubal ligation, bilateral oophorectomy or medically documented ovarian failure. Female subjects who are postmenopausal for less than two years are required to have FSH > 40 mIU/mL. If the FSH is = 40 mIU/mL, the subject must agree to use two forms of contraception to participate in the study.
Women are considered surgically sterile only if they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
Post menopause
1)Sex & Reproductive Status
a)WOCBP unwilling or unable to use an acceptable method to avoid
pregnancy (2 effective forms of contraception) for entire study period (on treatment) & for up to 24 weeks after last dose of investigational product or for duration specified in the label use for RBV in that country, whichever is longer
b)pregnant of breastfeeding Women
c)Women with + pregnancy test on enrollment or prior to IMP administration
d)Sexually active fertile men not using effective birth control if their partners are WOCBP
e)Sexually active fertile men whose partners are pregnant at screening
(contraindicated with RBV use)
2)Medical History & Concurrent Diseases
a)Evidence of medical condition associated with chronic liver disease other than HCV
b)Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria (in Stage 2)
c)Evidence of HCC documented by ultrasound (U/S), CT scan, or MRI within 12 months of randomization
d)Evidence of co-infection with HBV, HIV-1 or HIV-2 at screening
e)History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
f)Current or 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;
h)Any other medical, psychiatric &/or social reason including active substance or alcohol abuse, as defined by DMS IV, Diagnostic Criteria for Drug and Alcohol Abuse (see Protocol Appendix 3), which in opinion of the investigator, would make the candidate inappropriate for participation in this study
i)Inability to tolerate oral medication
j)Poor venous access
k)Liver transplant recipients
3)Physical & Laboratory Test Findings
a)ALT =5 x ULN
b)Total bilirubin =2 mg/dL (or = 34 µmol/L)
c)INR= 1.7
d)Albumin =3.5 g/dL (35 g/L)
e)Creatinine clearance as estimated by Cockcroft and Gault =50 mL/min
f)Any ECG finding which in opinion of the investigator would make the
candidate inappropriate for participation in this study (corrected QT value > 450 msec, second/third degree AV block, and bundle branch block)
4)Medical History or Laboratory Findings that Exclude Subject from pegIFNa or RBV Therapy
The following exclusion criteria are based on guidelines or recommendations from pegIFNa & RBV package inserts
a)Severe psychiatric disease, especially untreated or unstable depression, that would prohibit use of pegIFNa as judged by the investigator
b)History of hemoglobinopathies (ie, 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
c)Stage 1 - History of thyroid dysfunction n
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method