NL-OMON39072已完成2 期
Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive - AI452-005
Bristol-Myers Squibb0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Signed Written Informed Consent
- •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
- •- History of CHB infection defined as HBsAg positive at screening and on at least one other occasion for a least or more then 24 weeks prior to screening;
- •- Detectable HBeAg and no detectable HBeAb at screening and at least once for at least or more then 4 weeks prior to screening;
- •- Serum ALT 1.3 to < 10 x ULN at screening and on at least 1 other occasion within 24 weeks prior to screening, based on ULN where lab is performed with no value in the intervening period falling outside required range;
- •- HBV DNA by PCR at least or more then 105 copies/mL (17,200 IU/mL) at screening and presence of detectable HBV DNA at least once at least or more then 4 weeks prior to screening;
- •- No prior IFN therapy;
- •- Prior HBV nucleos(t)ide therapy allowed but not within 30 days prior to screening;
- •- Thyroid-stimulating hormone (TSH) and/or T4 within 0.8 to 1.2 times the normal limit, or adequately controlled thyroid function as assessed by the investigator;
- •- Documented baseline retinal exam performed within maximum 1 year of study randomization; any subjects with diabetes, hypertension, or other risk factors for retinal disease per assessment of the investigator can be included with a documented normal eye exam by a licensed ocular specialist;
- •- Pre-treatment liver biopsy performed within maximum 2 years prior to study randomization to characterize preexisting liver status. Patients with compensated cirrhosis will be allowed to participate but will be capped at 10%; patients with cirrhosis must not have decompensated liver disease.;3)Age and Reproductive Status
- •- Men or women, 18 - 70 years of age;
- •- Contraception Requirements: Women of childbearing potential (WOCBP, see Section 3.3.3 of the protocol for definition) and sexually active men with female partners who are WOCBP, must use 2 separate forms of contraception from screening throughout the duration of the study. One (1) form of contraception must be effective barrier method (eg, condom, diaphragm, cervical cap). Exceptions to this criteria are:
- •i)WOCBP who have vasectomized male partners for at least 6 months before enrollment
- •ii)Sexually active men who are vasectomized for at least 6 months before enrollment
- •- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product;
- •- Women must not be breastfeeding;
- •- Requirements for male subjects:
- •- Male subjects (unless vasectomized) 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 weekly pregnancy testing while the subjects is enrolled in the study), and agree to adhere to these recommendations; ;REVISED PROTOCOL 3 (Amendment 4 dd. 23 May 2011):
- •2)Target Population
- •a)History of CHB infection defined as HBsAg positive at screening and with other marker of HBV infection (eg, HBV DNA, HBeAg, HBV genotype) on at least one other occasion more then 24 weeks prior to screening;
- •c) Serum ALT > 47 U/L and
排除标准
- •1) Target Disease Exceptions
- •a) Co-infection with HIV, HCV or hepatitis D virus (HDV);
- •b) Evidence of a medical condition contributing to chronic liver disease other than HBV (such as but not limited to: hematochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, biliary disesase, hepatic steatosis, and toxin exposure).;2) Medical History and Concurrent Diseases
- •a) Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening;
- •b) Current evidence of or history of pancreatitis;
- •c) History of bone marrow or organ transplant or therapy with an immunomodulatory agent, cytotoxic agent, or systemic corticosteroids within 2 months of screening;
- •d) Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- •e) History of hepatocellular carcinoma (HCC) or for patients without a known history, evidence of HCC as documented by abdominal imaging (eg, ultrasound), within 18 months of study randomization;
- •f) 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).
- •g) Patients with other clinically significant ECG abnormalities (indicative of dysarrhythmia, myocardial ischemia or other serious cardiovascular disorder) at the time of screening in the opinion of the investigator;
- •h) Active substance abuse, such as alcohol, or inhaled or injected drugs, as defined by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), Diagnostic Criteria for Drug and Alcohol Abuse (Appendix 1) within 6 months prior to screening. Subjects who are receiving methadone or other substitutive product under medical supervision are eligible. Use of marijuana for medical purpose is allowed;
- •i) Prior or current history of cardiomyopathy or significant ischemic cardiac or cerebrovascular disease, including history of angina, myocardial infarction, interventional procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery);
- •j) Prior or current history of clinically significant hemoglobinopathy or hemolytic anemia;
- •k) Prior or current history of interstitial lung disease or sarcoidosis;
- •l) History of immunologically mediated disease (including, but not limited to, rheumatoid arthritis, inflammatory bowel disease, moderate to severe psoriasis [mild psoriasis is allowed], and systemic lupus erythematosus);
- •m) History of moderate, severe, or uncontrolled psychiatric disease; mild depression controlled at time of screening is allowed;
- •n) Active seizure disorder as defined by either untreated seizure disorder or continued seizure activity within the past year prior to screening despite treatment with anti-seizure medication;
- •o) Has, in the opinion of the investigator, any physical exam findings, laboratory abnormalities, or other medical, social, or psychosocial factors that may negatively impact compliance or subject*s safety by participation in this study; this should include conditions which may affect hematologic parameters such as prior or current history of porphyria cutanea tarda and/or hemophilia.;3) Physical and Laboratory Test
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