The Effective and Safety of Thalidomide in TI

• Status: Unknown status
• Trial end date: 2019-05-02
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion,60~100 patients will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiao-Lin Yin
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• Patients meeting all of the following criteria will be considered for admission to the trial:

• Diagnosis of NTDT;

• Ages 18-65 years;

• ECOG: 0~2 scores;

• If not blood transfusion,the level of HB<90g/dl, or blood transfusion to maintain the HB;

• Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

• Patients presenting with any of the following criteria will not be included in the trial:

• Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;

• Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;

• Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;

• Patients Allergic to the drug ingredients;

• Patients with any Mental problem;

• Patients had Participated in other drug clinical trials in the past 1 month;

• Patients had a history of venous or arterial thrombosis;

• In certain circumstances that the researchers determined it was not suitable for the research.