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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Completed; Phase 4

Conditions: Previously Treated Primary Immune Thrombocytopenia

Treatments: Drug: rhTPO; Drug: Eltrombopag

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05583838

IIT2022037

Details and patient eligibility

About

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

Full description

A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".

Enrollment: 157 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

Optimized rhTPO treatment

Experimental group

Description:

The study in a 2:1 randomization ratio (117 subjects to rhTPO group).

Treatment:

Drug: rhTPO

Eltrombopag treatment

Active Comparator group

Description:

The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).

Treatment:

Drug: Eltrombopag