Back to resultsTPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years (ITP)
Primary Purpose
Primary Immune Thrombocytopenic Purpura
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TPO-RA
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Thrombocytopenic Purpura
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.
Sites / Locations
- Institute of Hematology & Blood Diseases HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
100 subjects will be enrolled with the indicated treatment dose of TPO-RA
Outcomes
Primary Outcome Measures
Treatment response
Percentage of participants whose platelet count achieving response (R) within 6weeks.
Secondary Outcome Measures
Treatment response
Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment.
Treatment response
Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.
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).
Concomitant medication
The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.
Adverse events
Incidence of adverse events.
Full Information
NCT ID
NCT04890041
First Posted
May 12, 2021
Last Updated
October 28, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04890041
Brief Title
TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
100 subjects will be enrolled with the indicated treatment dose of TPO-RA
Intervention Type
Drug
Intervention Name(s)
TPO-RA
Other Intervention Name(s)
TPO-RAs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment response
Description
Percentage of participants whose platelet count achieving response (R) within 6weeks.
Time Frame
From the start of study treatment (Day 1) up to the end of week 6
Secondary Outcome Measure Information:
Title
Treatment response
Description
Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment.
Time Frame
From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Title
Treatment response
Description
Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.
Time Frame
From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Title
Duration of response
Description
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).
Time Frame
From the start of study treatment (Day 1) up to the end of week 6
Title
Concomitant medication
Description
The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.
Time Frame
From the start of study treatment (Day 1) up to the end of week 6
Title
Adverse events
Description
Incidence of adverse events.
Time Frame
From the start of study treatment (Day 1) up to the end of week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Liu
Phone
+82223909240
Email
liuwei1@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang
Phone
+82223909240
Email
zhanglei1@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Phone
+862223909240
Email
zhanglei1@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Phone
+82223909240
Email
zhanglei1@ihcams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
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