A single-center, single-arm prospective study of thalidomide combined with hydroxyurea in the treatment of ß thalassemia in children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054610

Enrollment

Unknown

Registered

2021-12-21

Start date

2021-12-20

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ß-thalassemia

Interventions

Experimental group:Thalidomide + Hydroxyurea

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5 to 18 years; 2. Diagnosed with ß-thalassemia intermedia or major (transfusion-dependent ß-thalassemia); 3. Ineffective after thalidomide treatment for >=6 months; 4. The patient and/or guardian have the ability to understand and voluntarily sign the informed consent; 5. No other drugs (such as hydroxyurea, EPO, etc.) that interfere with the treatment effect have not been taken for >=3 months before treatment; 6. Not participating in other clinical research projects within three months before enrollment.

Exclusion criteria

Exclusion criteria: 1. Complicated with liver, kidney and heart insufficiency diseases; 2. Combined with other malignant tumor diseases or rheumatic immune diseases; 3. There are contraindications to hydroxyurea and thalidomide (such as allergy, bone marrow suppression, pregnancy and breastfeeding); 4. Received bone marrow transplantation or gene editing treatment.

Design outcomes

Primary

Measure	Time frame
Transfusion volume;	—

Countries

China

Contacts

Public ContactFang Jianpei

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

jpfang2005@163.com+86 13682290830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026