Study of BMS-790052 Add-On to Standard of Care in Treatment NaiveSubjects

• Conditions: Chronic Hepatitis C; MedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-018295-24-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-25
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 625

Inclusion Criteria

1) Signed Written Informed Consent

2) Target Population
a) Subjects chronically infected with HCV genotype 1 or 4 (genotype 4 will be capped at 10% of the randomized study population), as documented by both positive HCV RNA and anti-HCV antibody at the time of screening, and positive HCV RNA, anti-HCV antibody, or HCV genotype test at least 6 months prior to screening;
b) HCV RNA viral load of = 105 IU/mL (100,000 IU/mL) at screening;
c) No previous exposure to interferon, pegIFNa, or RBV;
d) Results of a liver biopsy demonstrating the presence or absence of cirrhosis.
Compensated cirrhotics (based on clinical criteria) with HCV genotype 1 infection are eligible, but will be capped at 10% of the randomized study population. For eligible compensated cirrhotic subjects, biopsy documenting cirrhosis can be from any time period prior to randomization. For eligible non-cirrhotic subjects, liver biopsy results must be obtained = 24 months prior to randomization;
e) Ultrasound (U/S), computed tomography (CT) scan, or magnetic resonance imaging (MRI) results 12 months prior to randomization that do not demonstrate evidence of HCC;
f) Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/[height (m)]² at screening.

3) Age and Reproductive Status
a) Men or women, 18 - 70 years of age
b) Men and women of childbearing potential (WOCBP) must be using 2 separate methods of contraception to avoid pregnancy 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; see Protocol Section 3.3.3 for the definition of WOCBP.
c) Women 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 in this protocol.
d) Women must not be breastfeeding.
e) Requirements for male subjects (based on RBV label):
i) Male subjects (unless vasectomized for at least 6 months) with female partners who are WOCBP must agree to inform their females partners of the protocol-specified contraception requirements and pregnancy testing recommendations during treatment and post-treatment (ie, 2 forms of contraception and monthly pregnancy testing while the subject is enrolled in the study, and 6 months following discontinuation of RBV or the duration specified in the country-specific RBV-label), 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.
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 genotypes other than 1 or 4;
b) Positive HBsAg, or HIV-1/HIV-2 antibody at screening.

2) Medical History and Concurrent Diseases
a) 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);
b) Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria;
c) HCV genotype 4 subjects with compensated cirrhosis;
d) Current or known history of cancer within 5 years prior to enrollment (exceptions to this criteria are in situ carcinoma of the cervix or adequately controlled non-melanoma skin cancers);
e) Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug;
f) Any other medical, psychiatric and/or social reason including active substance abuse or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders IV (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;
g) Inability to tolerate oral medication;
h) Poor venous access.

3) Physical and Laboratory Test Findings
a) Confirmed ALT = 5 x ULN;
b) Confirmed total bilirubin = 34 µmol/L (or = 2 mg/dL);
c) Confirmed INR = 1.7;
d) Confirmed albumin = 3.5 g/dL (35 g/L);
e) Confirmed platelets = 90 x 10 billion cells/L;
f) Confirmed ANC = 1.5 x 10 billion cells/L;
g) Confirmed hemoglobin = 12 g/dL (120 g/L) for women and = 13 g/dL (130 g/L) for men;
h) Confirmed creatinine clearance (CrCl) (as estimated by Cockcroft and Gault) = 50 mL/min;
i) Patients with a screening QTcF > 450 msec (males) or > 470 msec (females), based on the average of 3 or more ECGs (ECGs obtained 5 minutes apart while subject is resting in a supine position).

4) Medical History or Laboratory Findings that Exclude Subjects from Peg-Interferon Alfa-2a or Ribavirin Therapy
The following exclusion criteria are based on guidelines or recommendations from the pegIFNa-2a and RBV package inserts:
a) Severe psychiatric disease, especially untreated or unstable depression, that would prohibit use of pegIFNa-2a 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 disease in which anemia would be medically problematic;
c) History of thyroid dysfunction not adequately controlled or screening thyroid function tests that indicate abnormal thyroid function;
d) History of chronic pulmonary disease associated with functional limitation;
e) Unstable or clinically significant cardiovascular disease or hypertension that could be expected to progress, recur or change during study period to such an extent that it could bias the assessment of the clinical status of the patient;
f) Pre-existing ophthalmologic disorders considered clinically significant on eye or retinal exam (all subjects with history of diabetes or hypertension must have a documented eye exam within 12 months prior to randomization);
g) History of uncontrolled diabetes mellitus;
h) Any known contraindication to peg-IFNa-2a or ribavirin, not otherwise specified.

5) Allergies and Adverse Drug Reaction
a) History of hypersensitivity to dr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified