2024-516862-12-00招募中3 期
Study of hydroxocobalamin at a new concentration for cobalamin-related remethylation disorders.
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年6月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- measurement of tHcy blood concentration at baseline and at 3-, 6-, 9-, 12-, 12-, 15-, 18- and 24-month follow-up and comparison of concentrations in both treatment arms
研究概览
简要总结
to determine whether the administration of high doses of hydroxycobalamin decreases the blood concentration of tHcy and to compare the decrease with treatment at standard doses.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment of study
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients under 2 years of age.
- •Patients with genetic diagnosis of any of the Cbl-RD diseases with early diagnosis who present ocular manifestations
- •Patients whose legal representative or, failing that, caregivers of the patient give written informed consent
- •Patients who, at the investigator's discretion, can complete the total follow-up of the study
排除标准
- •Premature patients born before 32 weeks of gestation
- •Patients with any other relevant pathology not associated with Cbl-RD diseases who, according to the physician's criteria, are not candidates to participate in the study.
- •Patients who present any contraindication to receive treatment with hydroxycobalamin, including hypersensitivity to the active ingredient (hydroxycobalamin) or to any of its excipients, according to the specifications of its data sheet
- •Participation in another clinical trial that prevents the patient's inclusion in the study
结局指标
主要结局
measurement of tHcy blood concentration at baseline and at 3-, 6-, 9-, 12-, 12-, 15-, 18- and 24-month follow-up and comparison of concentrations in both treatment arms
measurement of tHcy blood concentration at baseline and at 3-, 6-, 9-, 12-, 12-, 15-, 18- and 24-month follow-up and comparison of concentrations in both treatment arms
次要结局
未报告次要终点
研究者
Dra Maria Luz Couce Pico
Scientific
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
研究点 (4)
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