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

Primary Immune Thrombocytopenic Purpura Clinical Trial

— ITP  

Official title:

Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890041
• Other study ID #: SKX-ITP-001
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Wei Liu
• Phone: +82223909240
• Email: liuwei1[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment response	Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment.	From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Secondary	Treatment response	Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.	From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Secondary	Duration of response	Percentage of participants whose platelet count achieving persistence response (R) within 6weeks(defined as the proportion of subjects with a platelet count of =30×109/L for at least 4 weeks of the 6-week treatment period without remedial therapy).	From the start of study treatment (Day 1) up to the end of week 6
Secondary	Concomitant medication	The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.	From the start of study treatment (Day 1) up to the end of week 6
Secondary	Adverse events	Incidence of adverse events.	From the start of study treatment (Day 1) up to the end of week 6