2024-518594-33-00招募中3 期
Hydroxychloroquine in isolated cutaneous mastocytosis patients or indolent systemic mastocytosis with associated skin involvement patients: proof of concept study (HCQMa)
Centre Hospitalier Universitaire De Toulouse, Centre Hospitalier Universitaire De Toulouse2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is the change of mast cell activation symptoms as pruritus and/or flushes between the start of treatment and 12 months later.
研究概览
简要总结
To evaluate at 12 months the effect of hydroxychloroquine administered at a dose of 6 to 6.5mg / kg / day on mast cell activation symptoms as pruritus and / or flush moderate to severe in patients with isolated cutaneous mastocytosis and / or indolent systemic with associated skin involvement
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Isolated Cutaneous mastocytosis or indolent systemic mastocytosis with associated skin lesions defined according to WHO criteria (and / or international standards for cutaneous mastocytosis)
- •Patient with at least one disability defined by the presence of the following symptoms assessed as moderate to severe: a. Cutaneous pruritus with score ≥ 3 on a VAS scale from 0 to 10 b. Number of flushs / week ≥ 5
- •Skin KIT mutation known
- •Performance scale: OMS/ECOG ≤ 1
- •Woman and man of childbearing age under effective contraception during treatment with hydroxychloroquine and up to 8 months after stopping it
排除标准
- •Non-symptomatic mastocytosis and / or without skin involvement
- •Change symptomatic treatment (including dosage) in the 4 weeks preceding the inclusion visit
- •Inability to give informed consent
- •Inability to undergo medical monitoring for geographical, social or psychic
- •Patients with major surgery scheduled in the next two weeks screening
- •Patient without health insurance
- •Pregnancy, Breastfeeding
- •Vulnerable Patient, defined as: - Esperance survival < 6 months - Patient with another uncontrolled severe disease
- •Patient under juridical protection
- •Systemic mastocytosis with associated hematologic neoplasm (SMAHN)
- •Aggressive systemic mastocytosis
- •Mast cell leukemia
- •History of ophthalmic disease and / or cardiac conduction disorders against-indicating the use of hydroxychloroquine
- •Treatment with citalopram, escitalopram, hydroxyzine, domperidone, piperaquine due to the increased risk of ventricular rhythm disorders, especially torsades de pointes
- •Specific anti-tumor treatment (chemotherapy, radiotherapy) of less than 4 weeks before inclusion.
- •Concomitant specific anti-mast cell treatment
- •Inclusion in another trial with an experimental therapeutic molecule
结局指标
主要结局
The primary endpoint of this study is the change of mast cell activation symptoms as pruritus and/or flushes between the start of treatment and 12 months later.
The primary endpoint of this study is the change of mast cell activation symptoms as pruritus and/or flushes between the start of treatment and 12 months later.
次要结局
- - The difference on mast cell mass between the start of treatment and 12 months later
- The difference of other mast cell activation symptoms such as diarrhea, pollakiuria, arthralgia and discomfort between the start of treatment and 12 months later.
- The safety of hydroxychloroquine treatment
- The correlation of the effectiveness of treatment with the hydroxychloroquine and level of serum HCQ
研究者
Christina LIVIDEANU
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement PatientsMastocytosisNCT05084872University Hospital, Toulouse30
已完成
不适用
Study of the role of hydroxychloroquine in immunological and coagulation control in patients diagnosed with Primary antiphospholipid syndromeRBR-35mp4qHemocentro- Universidade Estadual de Campinas
进行中（未招募）
不适用
Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSASPulmonary SarcoidosisEUCTR2008-001340-39-ITIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
已完成
不适用
A study to estimate drug levels in health care workers on COVID infection prophylaxisCTRI/2020/05/025466orwich Clinical Services PvtLtd22
招募中
3 期
Effect of Hydroxychloroquine in patients with repeated implantation failureIRCT2017060634209N1Shahid Beheshti University of Medical Sciences30