EUCTR2009-012916-41-DE进行中（未招募）不适用
The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis (NASH) - a prospective open-label phase I/II trial - DEFINE
CROLLL GmbH0 个研究点开始时间: 2009年7月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 with elevated liver enzymes: transaminases (ALAT or ASAT) and/or g-GT = 1.5 ULN, max. 5 ULN
- •-Elevated serum ferritin: females > 300 ng/ml, males > 450 ng/ml
- •-Liver Histology consistent with a diagnosis of NASH (NAS Score = 3), as evaluated by the NASH activity scoring system (NAS) according to Kleiner DE et al. Hepatology 2005
- •-Males and females of age = 18 years
- •-Informed consent given
- •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
排除标准
- •-Alcohol intake > 140 g/week
- •-Established liver cirrhosis Child Pugh B or C
- •-Copresence of other causes of chronic liver disease, such as HBV/HCV infection, PSC, PBC, AIH, overlap syndromes, Wilsons Disease, alpha-1 AT deficiency, Porphyrias
- •-Anemia < 10 g/dl
- •-Elevation of liver enzymes: ALAT, ASAT, g-GT > 5 ULN; bilirubin > 1.5 ULN; elevation of > 2.5 ULN for other liver enzymes
- •-Serum creatinine > 1.4 mg/dl or Ccr < 60 ml/min
- •-Hemochromatosis (defined as homozygous state for the C282Y mutation documented by molecular diagnostic testing)
- •-Known allergy or contraindication to the administration of Deferasirox
- •-Lack of ability to comply with all study-related procedures, medications, and evaluations
- •-Sexually active pre-menopausal female patients who are unable to use double-barrier contraception, oral contraceptive plus barrier contraceptive. An exception is made for those who have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation. Postmenopausal is defined by amenorrhea for at least 12 months.
- •-History of blood transfusion during the 6 months prior to study entry
- •-Oral iron supplementation within the last 4 weeks of study entry
- •-Treatment with phlebotomy within 2 weeks of screening visit (V1)
- •-Desferal treatment within 1 month of the screening visit (V1)
- •-Patients currently or previously treated with deferiprone or Deferasirox
- •-Significant medical condition interfering with the ability to partake in this study
- •-Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug
- •-Positive HIV serology
- •-Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin
- •-Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation
- •-Illicit drug use
- •-Pregnant or breast feeding patients
- •-Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit (V1)
- •-Medications with proven or suspected influence on NASH such as glitazones, statins, or metformin are no exclusion criteria for study entry (insulin is not regarded to interfere with NASH). However, if any of these medications must be introduced or discontinued throughout the study for more than two weeks duration, the patient has to be excluded from final PP analysis. Changes in dose of preexisting medications (excluding insulin) will be registered and those patients will be further analysed in a subgroup analysis
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