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

NCT04890041 | Recruiting

• 1 other identifier: IIT2020033
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Primary Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• Treatment response

  Percentage of participants whose platelet count achieving response (R) within 6weeks.

  From the start of study treatment (Day 1) up to the end of week 6

Secondary Outcomes (5)

• Treatment response

  From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.

• Treatment response

  From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.

• Duration of response

  From the start of study treatment (Day 1) up to the end of week 6

• Concomitant medication

  From the start of study treatment (Day 1) up to the end of week 6

• Adverse events

  From the start of study treatment (Day 1) up to the end of week 6

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: TPO-RA

Interventions

TPO-RA 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.

Also known as: TPO-RAs

Treatment group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with secondary immune thrombocytopenia.
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Study Officials

• Lei Zhang

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu

CONTACT

+82223909240; liuwei1@ihcams.ac.cn

Lei Zhang

CONTACT

+82223909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: May 30, 2021
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)