The Effective and Safety of Thalidomide in NTDT

Thalassemia Clinical Trial

Official title:

The Phase II Clinical Trials of Thalidomide in NTDT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995707
• Other study ID #: 303PLA
• Status: Recruiting
• Phase: Phase 2
• First received: December 8, 2016
• Last updated: March 21, 2017
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: 303rd Hospital of the People's Liberation Army
• Contact: Liu Ch xu, President
• Phone: 0771 2870303
• Email: 530369641[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

• 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.

Related Conditions & MeSH terms

• Thalassemia

Intervention

Drug:
• Thalidomide
thalidomide:50mg/d p.o at bedtime

Locations

Country	Name	City	State
China	NO.3 Hospital of the Chinese People's Liberation Army	Nanjing	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Xiao-Lin Yin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of Hemoglobin	All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.	18 months
Secondary	The effects of relative and absolute values of HbF	The highest hemoglobin value will be observed,the value increased more than 20g/L defined as the marked effect, increased to 10~20g/L defined as effective, otherwise invalid.	18 months