The Effective and Safety of Thalidomide in NTDT

March 21, 2017 updated by: Xiao-Lin Yin

The Phase II Clinical Trials of Thalidomide in NTDT

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanjing, Guangxi, China, 530021
        • Recruiting
        • NO.3 Hospital of the Chinese People's Liberation Army

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: thalidomide thalassemia
thalidomide:50mg/d p.o
Drug: Thalidomide
thalidomide:50mg/d p.o at bedtime
Other Names:
  • fǎn yìng tíng

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of Hemoglobin
Time Frame: 18 months
All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of relative and absolute values of HbF
Time Frame: 18 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao-Lin Yin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303PLA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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