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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02995707
Other study ID # 303PLA
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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