EUCTR2013-000211-24-DE进行中（未招募）1 期
A multicenter, randomized, placebo-controlled, double-blind proof of concept study to evaluate the efficacy and safety of the human normal immunoglobulin Intratect® 5% for intravenous use as adjuvant therapy in patients with Pemphigus Vulgaris - IMAT-PV
Ruprecht-Karls-University Heidelberg0 个研究点目标入组 10 人开始时间: 2013年7月8日最近更新:
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
- 10
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
入选标准
- •1.Patients with clinical signs of Pemphigus vulgaris
- •2.Patients with Pemphigus vulgaris proven by direct immunofluorescence (deposition of IgG intraepidermally on the keratinocyte membrane)
- •3.Patients with relapse of Pemphigus vulgaris < 2 months before inclusion. (Relapse is defined by the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions in a person who has achieved disease control).
- •4.Prednisone doses (or the equivalent) = 10 mg per day
- •5.Indication for or therapy with additional immunosuppressive therapy (e.g. Azathioprine or Mycophenolatemofetil)
- •6.Age = 18years
- •7.Written informed consent, signed and dated
- •8.Sufficient knowledge of languages (German)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Patients with drug-induced forms of Pemphigus Vulgaris are excluded
- •2.Patients relapsing at a dose under 10 mg Prednisone (or the equivalent) per day
- •3.Clinically significant heart disease (NYHA Class III or IV)
- •4.Clinically significant renal insufficiency (CDC III or IV)
- •5.Patients with a history of thromboembolic episodes such as deep vein thromboses, myocardial infarction or stroke
- •6.HIV, HCV or HBV infections
- •7.Bleeding disorders
- •8.Patients with serious intercurrent illness, requiring hospitalization
- •9.Patients taking or requiring immunosuppressive drugs such as systemic corticosteroids other than study medication for a distinct medical disorder (e.g. rheumatoid arthritis). Topical or inhalational steroids are permitted
- •10.Patients treated with steroid pulse therapy, plasma exchange therapy within 30 days, other biotherapeutics (e.g. TNF-a inhibitors, interferons, rituximab) or HD-IVIg within 60 days before the start of study treatment.
- •11.Active malignancy within 1 year prior to entry into the study, except for cured non-melanoma skin cancer and cervical carcinoma in situ.
- •12.Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •13.Participation in chemotherapy or irradiation therapy within 4 weeks prior to enrolment.
- •14.Participation in any other clinical trial within 4 weeks prior to enrolment and treatment with another investigational agent within 5 elimination half-lives prior to enrolment.
- •15.Pregnancy or breastfeeding woman, or women of childbearing potential refusing or unable to use effective means of contraception (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, female sterilisation or condoms).
- •16.History of severe allergic reactions to study drugs, vaccines or unknown allergens
- •17.Patients with known absolute IgA deficiency
- •18.Patients who are unable to be treated due to obesity
- •19.Patients who are unable to receive concomitant immunosuppressive therapy
- •20.Suspicion of drug and / or alcohol abuse
- •The patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial
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