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临床试验/NCT07116772
NCT07116772招募中不适用

A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea

Children's Hospital Medical Center, Cincinnati3 个研究点 分布在 3 个国家目标入组 250 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
3
主要终点
Clinical Outcomes

研究概览

简要总结

The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.

详细描述

Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.

This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.

However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.

To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with documented sickle cell anemia (SCA).
  • At least 8 years of age at the time of enrollment.
  • Enrolled on the EXTEND or SACRED study.
  • Provide informed consent.
  • Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.

排除标准

  • Currently taking part in another treatment study (not EXTEND or SACRED).
  • Has received other treatments for sickle cell disease in the past 6 months.

研究组 & 干预措施

Sickle Cell Anemia

Those with sickle cell anemia (SCA).

结局指标

主要结局

Clinical Outcomes

时间窗: From enrollment up to 10 years after enrollment.

The number of people who experience serious health events like pregnancy, stroke, cancer, or death.

次要结局

  • Female Reproductive Potential and Outcomes(From enrollment up to 10 years after enrollment.)
  • Male Reproductive Potential and Outcomes(From enrollment up to 10 years after enrollment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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