NCT02995707

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

December 8, 2016

Last Update Submit

March 21, 2017

Conditions

Thalassemia

Keywords

Thalidomide NTDT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The effects of relative and absolute values of HbF

    18 months

Study Arms (1)

thalidomide thalassemia

EXPERIMENTAL

thalidomide:50mg/d p.o

Drug: Thalidomide

Interventions

ThalidomideDRUG

thalidomide:50mg/d p.o at bedtime

Also known as: fǎn yìng tíng
thalidomide thalassemia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 29931453DERIVED

MeSH Terms

Conditions

Thalassemia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic 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 2870303530369641@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

December 8, 2016

First Posted

December 16, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Three months later after the last visit，summery report will be shared with other researchers through database.

Locations

CN(1)