EUCTR2008-004562-10-FR进行中（未招募）1 期
Double-blind, randomised, placebo-controlled multicentre phase III clinical study followed by open-label phase on the efficacy and tolerability of budesonide 3 mg effervescent tablet in patients with resistant oral chronic GvHD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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. Signed informed consent
- •2. Man or woman between 18 and 75 years of age
- •3. Karnofsky= 70
- •4. Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation (cGvHD defined as GvHD present beyond day 100 post-transplantation)
- •5. Oral cGvHD confirmed by presence of at least one diagnostic clinical sign of cGvHD or presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests
- •6. Oral cGvHD of erosive and/or ulcerative type
- •7. NIH scale (15-point Schubert scale) = 3 but at least score 3 (moderate) for ulcers or at least score 2 (moderate) for erythema (lichenoid has to be present in case of absence of ulcers)
- •8. Resistant oral cGvHD with no oral response defined as the lack of partial response to conventional primary treatment (i.e. systemic prednisone and/or cyclosporine) after 4 weeks
- •9. In case of conventional primary treatment (i.e. systemic prednisone and/or cyclosporine) dosage unchanged within the last 4 weeks before inclusion (dose reduction and dose adjustment by therapeutic drug monitoring [TDM] allowed)
- •10. In case of treatment with tacrolimus (FK506), sirolimus (rapamycin), or mycophenolate mofetil (MMF) dosage unchanged within the last 4 weeks before inclusion (dose reduction and dose adjustment by TDM allowed)
- •11. Negative pregnancy test at baseline visit week 0 in females of childbearing potential
- •12. Male or female patients with reproductive potential must use an approved contraceptive method during study treatment evaluation
- •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
- •1. Uncertain diagnosis of resistant oral cGvHD
- •2. Symptomatic oral cGvHD of hyperkeratotic type solely
- •3. Current active oral bacterial, viral, or fungal infection
- •4. Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain (including viscous lidocaine, topical antifungals, or mouthwashes)
- •5. Requiring addition of new systemic therapy including steroids, or radiation therapy
- •6. Local intestinal infection
- •7. Abnormal hepatic function or liver cirrhosis(ALT or AST > 3 x ULN)
- •8. If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
- •9. Second line treatment of oral cGvHD with topical steroids (e.g. dexamethasone, beclomethasone) within the last 4 weeks
- •10. Use of inhaled steroids for the treatment of e.g. COPD or bronchiolitis
- •11. Treatment with low dose total lymphoid irradiation, intraoral PUVA, extracorporeal photochemotherapy, thalidomide, pentostatin within the last 4 weeks
- •12. Treatment with ketoconazole, itraconazole or other CYP3A inhibitors except fluconazole, voriconazole, cyclosporine, and tacrolimus/FK506 (increase of dose not allowed, see inclusion criteria 9 and 10)
- •13. Unable to demonstrate appropriate use of study medication
- •14. Existing or intended pregnancy or lactation
- •15. Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile
- •16. Participation in another clinical study for the treatment of cGvHD within the last 30 days or simultaneous, or previous participation in this study
- •17. Well-founded doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs
研究者
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