The Effective and Safety of Thalidomide in TI

NCT03184844 | Unknown Phase 2

• 1 other identifier: 303 PLA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia

Keywords

Thalidomide TI

Outcome Measures

Primary Outcomes (1)

• The Effective Rate of Patients

  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.

  24 months

Secondary Outcomes (1)

• The Marked Improvement Rate of Patients

  24 months

Study Arms (1)

thalidomide thalassemia

EXPERIMENTAL

thalidomide:50mg/d p.o

Drug: Thalidomide

Interventions

Thalidomide DRUG

thalidomide:50mg/d p.o at bedtime

Also known as: fǎn yìng tíng

thalidomide thalassemia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiao-Lin Yin: lead

Study Sites (1)

NO.3 Hospital of the Chinese People's Liberation Army

Nanjing, Guangxi, 530021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29931453 DERIVED

MeSH Terms

Conditions

Thalassemia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yin X Lin, director

  NO.3 Hospital of the Chinese People's Liberation Army

  STUDY DIRECTOR

Central Study Contacts

Liu Ch xu, President

CONTACT

0771 2870303; 530369641@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, NO.3 Hospital of the People's Liberation Army

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: May 2, 2017
• Primary Completion: February 2, 2019
• Study Completion: May 2, 2019
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)