EUCTR2011-000756-42-DE进行中（未招募）不适用
A phase 2, multicentre, single arm, pilot study to assess the efficacy and the safety of 150 mg twice a day oral DF2156A in patients with active bullous pemphigoid. - DF2156A in patients with active bullous pemphigoid
Dompé s.p.a.0 个研究点目标入组 12 人开始时间: 2011年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- •To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria.
- •- Male and female patients aged >50 years.
- •- Patients with newly diagnosed or relapsing bullous pemphigoid based on clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin (or BP180 and/or BP230 ELISA). Confirmation by laboratory tests will be obtained ideally before or anyway within one week after enrolment.
- •For the purpose of this study, clinical relapses are defined as re-appearance of clinical symptoms after the patient had attained remission lasting for more than 3 months without immunosuppressive treatment. In patients with relapsing BP, clinical diagnosis will be confirmed by indirect immunofluorescence or BP180 and/or BP230
- •ELISA only.
- •- Patients with mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions.
- •- Patients with modified ABSIS score =50
- •- Patients free from any systemic treatments that may affect the course of the disease with the following off-period prior to enrolment:
- •- 3 weeks: steroids, dapsone, tetracyclines, nicotinamide,
- •- 3 months: azathioprine, mycofenolate mofetil, cyclophosphamide,
- •methotrexate, intravenous immunoglobulins, immunoadsorption, TNF
- •antagonists
- •- 12 months: rituximab, leflunomide
- •- Patients free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment.
- •- Patients able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
- •- Patients able to provide informed consent.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Patients with a Karnofsky rating score <40%.
- •- Patients with mucosal involvementPatients with moderate to severe renal impairment as per calculated creatinine clearance (CLcr) < 50 mL/min according to the Cockcroft-Gault formula (Cockcroft- Gault, 1976).
- •- Patients with hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 µmol/L].
- •- Patients with hypoalbuminemia defined as serum albumin < 3 g/dL.
- •- Patients with a baseline (day 0/1, pre-dose) QTcF > 470 msec.
- •- Patients who had a myocardial infarction in the 6 months prior to enrolment.
- •- Patients on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (> 50 mg/day).
- •- Patients with known hypersensitivity to non-steroidal antiinflammatory drugs.
- •- Patients using any investigational agent within 12 months prior to enrolment.
- •- Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males).
- •Patients with hypokalemia defined as serum potassium < 3.5 mmol/L.
- •- Patients with clinically relevant bradycardia (heart rate < 50 beats/min)
- •- Patients with a complete left bundle branch block.
- •- Patients with a history of uncontrolled or labile hypertension
- •- Patients with a history of congestive heart failure.
- •- Patients with a history of cardiomiopathy.
- •- Patients with unstable angina pectoris
- •- Patients with a personal or family history of congenital or documented acquired QT interval prolongation
- •- Patients with a significant atrial or ventricular arrhythmia or symptomatic arrhythmia in the past.
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