Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 5, 2016
August 1, 2016
2.9 years
July 26, 2016
August 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to platelet transfusion independence in patients at 6 month
6 month
Secondary Outcomes (10)
Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L
up to 1year
Overall response rate up to 1 year after Immunosupressive therapy.
up to 1 year
Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST.
up to 1 year
Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST
up to 1 year
Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST.
up to 1 year
- +5 more secondary outcomes
Study Arms (2)
rhTPO
EXPERIMENTALrhTPO injection
control
PLACEBO COMPARATORwithout rhTPO injection
Interventions
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent
- Have severe or very severe aplastic anemia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zonghong Shao
Tianjin, Tianjin Municipality, 300052, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of department of Hematology
Study Record Dates
First Submitted
July 26, 2016
First Posted
August 5, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2020
Last Updated
August 5, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share