EUCTR2010-019884-12-DE进行中（未招募）1 期
Induction of Fibrosis Regression regarding Chronic Hepatitis B Infection - INFIRE
niversitätsklinikum Aachen0 个研究点目标入组 100 人开始时间: 2010年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Patients aged 18 to 75 years at the time of inclusion in the study
- •Written informed consent of the patient
- •Chronic hepatitis B infection (cHBV) with detectable HBV-DNA at study start
- •Availability of results from a recent liver biopsy. The date of the liver biopsy may not be more than six months before the day of the screen-ing visit.
- •Evidence for relevant liver fibrosis in the liver histology after percutane-ous or laparoscopic puncture (histologically >= F2) according to the as-sessment of an experienced pathologist and sufficient evaluability of the biopsy material (as a rule, evaluation of at least eight portal fields) or clinical evidence of a liver cirrhosis (on the basis of unequivocal endo-scopic or sonographic indications). The number of patients included with clinical evidence for a liver cirrhosis may not exceed 40%. After in-clusion of 40 patients (= 40%) with clinical evidence for a liver cirrhosis all study centres will be notified not to include more patients from this subgroup
- •Therapy indication according to the current guidelines for the cHBV infection (i.e. every virus replication in patients with liver cirrhosis or de-tection of an HBV-DNA >= 2000 IU/ml and/or liver histology with inflam-mation >= degree 2/ fibrosis >= stage 2 and ALT < 5 x ULN)
- •Non-pregnant (verified by a negative pregnancy test) and non-breast feeding women fulfilling at least one of the following criteria:
- •?-post-menopausal (12 months natural amenorrhea or six months amenorrhea with serum FSH > 40mlU/ml)
- •?-6 weeks after operative sterilisation by bilateral tubal ligation or bi-lateral ovarectomy with or without hysterectomy
- •?-Correct use of two methods for reliable contraception. This includes any combination of a hormonal contraceptive (pill, intra-uterine spi-ral, depot injection, hormone implant, hormone patch or vaginal ring) or an intra-uterine device with spermicidal barrier contracep-tive agent (diaphragm, cervical cap, lea contraceptivum, femidom or condom) or a spermacide
- •?-Sexual abstinence from two weeks before the first administration of the investigational medicinal product (IMP), during the entire dura-tion of the study, and 30 days following the study, covering the elimination of the IMP
- •-Patients with only female sexual partners
- •-Male partner of a patient who is sterile before inclusion of the fe-male patient in the study and is the only sexual partner of the fe-male patient
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Anamnestically known hypersensitivity to Baraclude® or its components or to medication with a similar chemical structure
- •Participation of the patient in another clinical study within the last four weeks before inclusion or simultaneous participation in another clinical study
- •Anamnestically known addictive or other disorders, which do not allow the person to assess the nature, impact and possible consequences of the clinical study
- •Indications that the patient will probably not comply with the study pro-tocol (e.g. lack of willingness to co-operate)
- •Anamnestically known co-infection with hepatitis C, hepatitis D or HIV
- •Evidence for a hepatocellular carcinoma
- •Severe chronic disease with an estimated survival prognosis of less than three years
- •Any previous therapy with lamivudine or telbivudine or previous therapy within the last six months before inclusion in the clinical study with an-other active anti-viral drug
- •Contra-indications for taking entecavir
- •Creatinine clearance < 50ml/min and/or need for haemodialysis
- •MELD Score > 15 points and/ or evidence for ascites
研究者
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