EUCTR2009-013652-69-DE进行中（未招募）不适用
A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection.Revised Protocol 05, incorporating Protocol Amendments 03, 05, 06, 07 and 08.+ Pharmacogenetics Blood Sample Protocol Amendment 01 (v2.0, Dated 12-Nov-2009).
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 435
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
- •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 is defined as:
- •Amenorrhea = 12 consecutive months without another cause or
- •For women with irregular menstrual periods and on hormone replacement
- 另有 3 项未显示
排除标准
- •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
- •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 not adequately controlled or screening thyroid function tests that indicate abnormal thyroid function
- •Stage 2 - Thyroid-stimulating hormone (TSH) &/or free T4 < 0.8 times
- •the LLN or more than 1.2 times > ULN
- 另有 5 项未显示
研究者
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