CTRI/2024/03/063760尚未招募3 期
Prospective, Randomised, Double blind, Parallel-group Study to Assess the Safety and efficacy of 2/5mg Once Daily Nitisinone among Indian Patients with Alkaptonuria – A randomised control trial. - Nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients harboring HGD pathogenic variant.
- •Any Clinical manifestations of AKU, such as clinical ochronosis or chronic back/joint pain.
- •Age 18 – 45 years.
- •Willing and able to visit the investigational site for study visits.
- •Signed written informed consent given.
排除标准
- •Currently pregnant or lactating.
- •Uncontrolled hypertension (blood pressure greater than 180 mmHg systolic or greater than 95 mmHg diastolic).
- •Unstable cardiovascular disease.
- •History of alcohol or drug abuse.
- •Psychiatric or somatic illness that interferes with compliance or communication with health care personnel.
- •Any other medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
研究者
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