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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thalidomide thalassemia | Experimental | thalidomide:50mg/d p.o |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | thalidomide:50mg/d p.o at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| The level of Hemoglobin | All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Patients meeting all of the following criteria will be considered for admission to the trial:
Exclusion Criteria:
Patients presenting with any of the following criteria will not be included in the trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Ch xu, President | Contact | 0771 2870303 | 530369641@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yin X Lin, director | NO.3 Hospital of the Chinese People's Liberation Army | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NO.3 Hospital of the Chinese People's Liberation Army | Recruiting | Nanjing | Guangxi | 530021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29931453 | Derived | Ren Q, Zhou YL, Wang L, Chen YS, Ma YN, Li PP, Yin XL. Clinical trial on the effects of thalidomide on hemoglobin synthesis in patients with moderate thalassemia intermedia. Ann Hematol. 2018 Oct;97(10):1933-1939. doi: 10.1007/s00277-018-3395-5. Epub 2018 Jun 22. |
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Three months later after the last visit,summery report will be shared with other researchers through database.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 11, 2017 | |
| Unrelease | Yes | |
| Release | Jun 12, 2017 | |
| Unrelease | Yes | |
| Release | Aug 1, 2017 | |
| Reset | Aug 29, 2017 | |
| Release | Sep 15, 2017 | |
| Reset | Oct 12, 2017 | |
| Release | Oct 25, 2017 | |
| Reset | Jul 27, 2018 | |
| Release | Aug 13, 2018 | |
| Reset | Jan 18, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2017 | Yes | |||
| Jun 12, 2017 |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Yes |
| Aug 1, 2017 | Aug 29, 2017 |
| Sep 15, 2017 | Oct 12, 2017 |
| Oct 25, 2017 | Jul 27, 2018 |
| Aug 13, 2018 | Jan 18, 2019 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |