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

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University General Hospital

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.