Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
NCT06478537

TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination

Led by Peking Union Medical College Hospital · Updated on 2024-06-27

56

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia (ITP) can induce immune tolerance, develop immune balance in ITP patients, and enable patients to achieve a sustained response (SRoT) after TPO-RA discontinuation.

CONDITIONS

Official Title

TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Newly diagnosed or persistent primary ITP patients with inadequate response or relapse after first-line corticosteroid treatment with or without IVIg
  • Complete response with platelet count above 100 x 10^9/L after hetrombopag treatment at doses of 2.5mg to 7.5mg per day
  • Willing to participate in the study, provide informed consent, and complete all trial procedures
Not Eligible

You will not qualify if you...

  • Age over 50 years
  • Contraindication to aspirin use
  • Past arterial or venous thrombosis or clinical history indicating clotting disorders
  • Cardiovascular risk factors such as hypertension, diabetes, or high cholesterol
  • Recent (within 3 months) serious heart conditions including severe heart failure, arrhythmias, or prolonged QT interval
  • Current use of anticoagulant or antiplatelet therapy
  • Females receiving estrogen replacement therapy or oral contraceptives
  • Current or past malignant tumors
  • Secondary thrombocytopenia or other blood disorders causing low platelets
  • Significant bone marrow fibrosis or other primary diseases causing thrombocytopenia
  • Elevated liver enzymes or kidney function tests above specified limits
  • History of liver cirrhosis or portal hypertension
  • Uncontrolled infections
  • Positive hepatitis B or C infection markers
  • Positive HIV or syphilis antibody tests
  • Known allergy to the study drug or its ingredients
  • Breastfeeding, pregnant, or planning to conceive during the study
  • Other conditions judged unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

T

Tienan Zhu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination | DecenTrialz