EUCTR2010-022408-28-DK进行中（未招募）不适用
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+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0 dated 15-Oct-10)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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/m², inclusive. BMI = weight (kg)/[height (m)]² 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.
- •ii) Exceptions include:
- •(1) WOCBP who are not heterosexually active or who have male partners who have been vasectomized for a minimum of 6 months;
- •(2) Sexually active men who are vasectomized for a minimum of 6 months.
- •b) Female Subjects: Requirements for pregnancy testing:
- •iii) WOCBP who do not meet the exceptions listed above must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/mL or equivalent units of HCG) within 24 hours prior to the start of investigational product.
- •(1) Female subjects must not be breastfeeding;
- •(2) Female subjects must agree to the pregnancy testing requirement in this protocol.
- •c) Male Subjects: Requirements (based on RBV label):
- •iv) Male subjects (unless vasectomized) with female partners who are WOCBP must agree to inform their female partners of, and agree to adhere to, the protocol-specified contraception requirements and pregnancy testing recommendations during treatment and post-treatment (2 forms of contraception and monthly pregnancy testing while the subject is on study treatment and for 6 months after the last dose of RBV [or for the post-treatment duration specified in the country-specific RBV label]).
- •v) Male subjects must confirm that their female sexual partners are not pregnant
- •at the time of screening.
- •Are the trial subjects under 18? no
排除标准
- •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
- •a)Confirmed ALT =5 x ULN;
- •b)Confirmed Total Bilirubin =34 µmol/L (=2 mg/dL);
- •c)Confirmed INR =1.7;
- •d)Confirmed Albumin =3.5 g/dL (35g/L);
- •e)Confirmed Platelets =90×10 billion cells/L;
- •f)Confirmed ANC =1.5×10 billion cells/L (Confirmed ANC =1.2×10 billion cells/L for blacks);
- •g)Confirmed Hemoglobin =12g/dL (120 g/L) for women and =13g/dL (130 g/L) for men;
- •h)Confirmed Creatinine Clearance (CrCl) =50 mL/min (as estimated by Cockcroft and Gault);
- •i)Alpha fetoprotein (AFP);
- •i)AFP >100 ng/mL OR
- •ii)AFP =50 and =100 ng/mL requires a liver ultrasound and subjects with findings suspicious for HCC are excluded.
- •j)QTcF > 450 mSec (males) or > 470 mSec (females);
- •k)Positive HBsAg, HIV-1 or HIV-2 Ab.
- •4)Allergies and Adverse Drug Reaction
- •a)History of hypersensitivity to drugs with a similar biochemical structure to BMS-790052, pegIFNa-2a, or RBV.
- •5)Sex and Reproductive Status
- •a)Males and females who do not or cannot meet Inclusion Criterion 3;
- •b)Sexually active fertile men whose partners are pregnant at screening.
- •6)Prohibited Treatments and/or Therapies
- •a)Prior exposure to any HCV direct antiviral agent;
- •b)Exposure to any investigational drug or placebo within 4 weeks of study drug administration;
- •c)Long term treatment with immunosuppressive age
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