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