Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia
NCT ID: NCT02857530
Last Updated: 2016-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
250 participants
INTERVENTIONAL
2016-08-31
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rhTPO
rhTPO injection
rhTPO
rhTPO
control
without rhTPO injection
placebo
without rhTPO
Interventions
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rhTPO
rhTPO
placebo
without rhTPO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have severe or very severe aplastic anemia
Exclusion Criteria
* 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.
6 Years
60 Years
ALL
No
Sponsors
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Tianjin Medical University General Hospital
OTHER
Responsible Party
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ZhongHong Shao
head of department of Hematology
Locations
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Zonghong Shao
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB2013-066-01
Identifier Type: -
Identifier Source: org_study_id
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