NCT02995707

The Effective and Safety of Thalidomide in NTDT

The Phase II Clinical Trials of Thalidomide in NTDT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiao-Lin Yin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.15\~30 patients will be enrolled, including type α 5\~13 cases, type β 10\~17 cases.

Detailed description

The project is a single arm research of thalidomide in NTDT,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18\~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Subjects should take thalidomide 50mg per day for 12 weeks. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit, 4-weeks visit, 8-weeks visit and 12-weeks visit.

Conditions

• Thalassemia

Interventions

Type	Name	Description
DRUG	Thalidomide	thalidomide:50mg/d p.o at bedtime

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2016-12-16
• Last updated: 2017-03-22

Locations

1 site across 1 country: China