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The Effective and Safety of Thalidomide in TI

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ClinicalTrials.gov Identifier: NCT03184844
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Xiao-Lin Yin, 303rd Hospital of the People's Liberation Army

Brief 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.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: Thalidomide Phase 2

Detailed Description:
The project is a single arm research of thalidomide in TI,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. 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,1-month visit, 3-months visit , 6-months visit ,9-months visit, 12-months visit and 15-months visit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Multi-center Clinical Trials of Thalidomide in TI
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : February 2, 2019
Estimated Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: thalidomide thalassemia
thalidomide:50mg/d p.o
Drug: Thalidomide
thalidomide:50mg/d p.o at bedtime
Other Name: fǎn yìng tíng




Primary Outcome Measures :
  1. The Effective Rate of Patients [ Time Frame: 24 months ]
    All participants will complete the treatment for 24 months, the hemoglobin value will be observed during the treatment,the value increased more than 20g/L defined as the marked effect,increased to 10~20g/L defined as effective, otherwise invalid.


Secondary Outcome Measures :
  1. The Marked Improvement Rate of Patients [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184844


Contacts
Contact: Liu Ch xu, President 0771 2870303 530369641@qq.com

Locations
China, Guangxi
NO.3 Hospital of the Chinese People's Liberation Army Recruiting
Nanjing, Guangxi, China, 530021
Contact: Li L Zhu, Assistant    0771 2870303    530369641@qq.com   
Sponsors and Collaborators
Xiao-Lin Yin
Investigators
Study Director: Yin X Lin, director NO.3 Hospital of the Chinese People's Liberation Army

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiao-Lin Yin, Director, NO.3 Hospital of the People's Liberation Army, 303rd Hospital of the People's Liberation Army
ClinicalTrials.gov Identifier: NCT03184844     History of Changes
Other Study ID Numbers: 303 PLA
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Twenty four months later after the last visit,summery report will be shared with other researchers through database

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiao-Lin Yin, 303rd Hospital of the People's Liberation Army:
Thalidomide TI

Additional relevant MeSH terms:
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents