EUCTR2009-017869-27-DE进行中（未招募）不适用
A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis.
niversity Hospital Zurich0 个研究点目标入组 14 人开始时间: 2010年7月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
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.Male or female patients of age between > 18 and < 75 years
- •2.Patients fulfilling the American College of Rheumatology criteria for systemic sclerosis (SSc)
- •3.Diffuse cutaneous SSc (dcSSc) according to the LeRoy criteria
- •4.Female patients of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus spermicidal gel, or spermicidal gel plus condom up to Study Completion visit
- •5.Male patients must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit
- •6.Capability of understanding the nature of the study and giving written informed consent
- •7.Willingness and ability to comply with the study protocol for the duration of the study
- •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
- •1Major surgery within two months prior to treatment start
- •2Any of the following abnormal baseline hematological values
- •Hb < 10g/dl
- •WBC < 3.0 x 10^9/l
- •Neutrophils < 1.5 x 10^9/l
- •Platelets < 100 x 10^9/l
- •3Any of the following abnormal baseline liver function tests:
- •Serum bilirubin > 2.0 x upper normal limit
- •ALAT and/or ASAT > 5.0 x upper normal limit
- •4The following abnormal baseline renal function test:
- •Serum creatinine > 1.5 mg/dl
- •Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault criteria:
- •[CLcrea = Weight (kg) x (140 – Age)/72 x serum creatinine concentration]
- •For male: x 1, for female: × 0.85
- •5Renal crisis (acute onset of renal failure, moderate to marked hypertension, and normal urine sediment with mild proteinuria) in the 2 months prior to treatment
- •6All Cardiovascular: clinically relevant abnormalities, i.e. myocardial infarction within the prior six months, cardiac arrhythmia requiring medication, evidence of fibrosis on heart valves, or uncontrolled hypertension
- •7Abnormal cardiac function or non compensated active heart disease (* class II of NYHA classification)
- •FVC < 50% predicted
- •CO diffusion capacity < 40% predicted
- •Pseudo obstruction
- •Malabsorption requiring parenteral nutrition
- •10History of psychiatric disabilities, seizures or central nervous system disorders thought to be clinically relevant in the opinion of the Investigator that could interfere with informed consent or adequate follow-up
- •11Treatment with other potentially disease modifying agents during the last 3 months, including prednisone or corticosteroid equivalent in doses higher than 15 mg/d. Doses of prednisone lower than 15 mg/d are allowed
- •12Serious (grade 3-4) uncontrolled intercurrent infections
- •13Evidence or history of drug or alcohol abuse
- •14Participation in any investigational drug study within 60 days preceding treatment start or during the study
- •15Pregnancy or breast feeding women
- •16Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study
研究者
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