CompletedPhase 4
A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
Key facts
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Where
- China17 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 157 people enrolled
- Started
- 22 Nov 2022
- Ended
- 16 Jul 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- rhTPO
- Eltrombopag
- Record updated
- 24 April 2025
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year
- Subjects who are known nonresponders to rhTPO or TPO-RA therapy
- Subjects with any prior history of tumor
- Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days
- 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
- Classified as refractory ITP
- Female subjects who are nursing or pregnant
- Any situation that investigate consider not suitable for pts to join the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.
The 2 groups in the trial
- Optimized rhTPO treatmentTreatment being tested
The study in a 2:1 randomization ratio (117 subjects to rhTPO group).
Treatment: rhTPO
- Eltrombopag treatmentExisting treatment, for comparison
The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group).
Treatment: Eltrombopag
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial
- Record updated
- 24 April 2025