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

T

Tianjin Medical University

Status and phase

Unknown
Phase 2

Conditions

Anemia, Aplastic

Treatments

Drug: rhTPO
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02857530
IRB2013-066-01

Details and patient eligibility

About

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.

Full description

rhTPO

Enrollment

250 estimated patients

Sex

All

Ages

6 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

250 participants in 2 patient groups, including a placebo group

rhTPO
Experimental group
Description:
rhTPO injection
Treatment:
Drug: rhTPO
control
Placebo Comparator group
Description:
without rhTPO injection
Treatment:
Drug: placebo

Trial contacts and locations

1

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Central trial contact

ZONGHONG SHAO, MD.

Data sourced from clinicaltrials.gov

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