TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years

NCT ID: NCT04890041

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2025-12-31

Brief Summary

This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .

Detailed Description

The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.

100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.

Conditions

Primary Immune Thrombocytopenic Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

100 subjects will be enrolled with the indicated treatment dose of TPO-RA

Group Type: EXPERIMENTAL

TPO-RA

Intervention Type: DRUG

The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.

Interventions

TPO-RA

The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.

Intervention Type: DRUG

Other Intervention Names

TPO-RAs

Eligibility Criteria

Inclusion Criteria

• Men and women greater than or equal to 14 years of age.
• Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
• Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
• Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.

Exclusion Criteria

• Patients diagnosed with secondary immune thrombocytopenia.
• A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
• Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
• Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
• Have used rituximab in the past 3 months;
• Splenectomy in recent 3 months;
• Those who are not considered suitable for this study by the researcher;
• Women who are pregnant or who intend to become pregnant in the near future are excluded.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Liu

Role: CONTACT

liuwei1@ihcams.ac.cn

+82223909240

Lei Zhang

Role: CONTACT

zhanglei1@ihcams.ac.cn

+82223909240

Facility Contacts

Lei Zhang, MD

Role: primary

zhanglei1@ihcams.ac.cn

+862223909240

Lei Zhang

Role: backup

zhanglei1@ihcams.ac.cn

+82223909240

Other Identifiers

IIT2020033

Identifier Type: -

Identifier Source: org_study_id