A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborators: Cangzhou Central Hospital; Daqing Oil Field Hospital; Henan Cancer Hospital; North China University of Science and Technology Affiliated Hospital; Second Affiliated Hospital of Guangzhou Medical University; Second Hospital of Shanxi Medical University; Shaanxi Provincial People's Hospital; Shenyang Sunshine Pharmaceutical Co., LTD.; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The Affiliated Hospital of Inner Mongolia Medical University; The Second Affiliated Hospital of Dalian Medical University; The Second Affiliated Hospital of Harbin Medical University; The Second Affiliated Hospital of Kunming Medical University; The Second Hospital of Hebei Medical University; Xijing Hospital; Yuncheng Central Hospital

Criteria

Inclusion Criteria:

• Subject is ≥18 years old.

• Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.

• Baseline platelet count <30×10^9/L.

• Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.

• Informed consent has been signed.

Exclusion Criteria:

• Classified as refractory ITP.

• Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.

• Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.

• Subjects who are known nonresponders to rhTPO or TPO-RA therapy.

• Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA >1000cps/ml.

• TBil or Scr> 1.5 x upper limit of normal (ULN), ALT or AST> 3.0 x ULN in recently 2 weeks.

• Subjects with any prior history of tumor.

• Female subjects who are nursing or pregnant.

• Any situation that investigate consider not suitable for pts to join the study.