Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

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Brief Title

Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Official Title

Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Brief Summary

      Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic
      anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II
      phase, multi-center clinical research.

Detailed Description

      rhTPO

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Time to platelet transfusion independence in patients at 6 month

Secondary Outcome

 Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L

Condition

Anemia, Aplastic

Intervention

rhTPO

Study Arms / Comparison Groups

 rhTPO
Description:  rhTPO injection

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

250

Start Date

August 2016

Completion Date

July 2020

Primary Completion Date

July 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Able to provide written informed consent

          -  Have severe or very severe aplastic anemia

        Exclusion Criteria:

          -  Have diagnosis of Fanconi anemia

          -  Have infection not adequately responding to appropriate therapy

          -  Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater
             than or equal to 50%

          -  Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal

          -  Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper
             limit of normal if the patient has been treated with Anti-Thymocytes globulin（ATG）
             within three weeks of screening.

          -  Have glutamic-oxaloacetic transaminase （AST） and/or glutamic-pyruvic transaminase
             （ALT） ≥ 3 times the upper limit of normal

          -  Are female and are nursing or pregnant or are unwilling to take oral contraceptives or
             refrain from pregnancy if of childbearing potential

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater

          -  Have had other Thrombopoietin (TPO-R) agonists medication in the previous 4 weeks.

Gender

All

Ages

6 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, 8613702036467, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02857530

Organization ID

IRB2013-066-01

Responsible Party

Principal Investigator

Study Sponsor

Tianjin Medical University General Hospital

Study Sponsor

, ,

Verification Date

August 2016