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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04890041
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
Zhang Lei, MD, Institute of Hematology & Blood Diseases Hospital

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Primary Immune Thrombocytopenic Purpura Drug: TPO-RA Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
100 subjects will be enrolled with the indicated treatment dose of TPO-RA
 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.
Other Name: TPO-RAs


Outcome Measures
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Primary Outcome Measures :
  1. Treatment response [ Time Frame: From the start of study treatment (Day 1) up to the end of week 6 ]
    Percentage of participants whose platelet count achieving response (R) within 6weeks.


Secondary Outcome Measures :
  1. Treatment response [ Time Frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6. ]
    Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment.

  2. Treatment response [ Time Frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6. ]
    Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.

  3. Duration of response [ Time Frame: From the start of study treatment (Day 1) up to the end of week 6 ]
    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).

  4. Concomitant medication [ Time Frame: From the start of study treatment (Day 1) up to the end of week 6 ]
    The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.

  5. Adverse events [ Time Frame: From the start of study treatment (Day 1) up to the end of week 6 ]
    Incidence of adverse events.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890041


Contacts
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Contact: Wei Liu +82223909240 liuwei1@ihcams.ac.cn
Contact: Lei Zhang +82223909240 zhanglei1@ihcams.ac.cn

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital Recruiting
Tianjin, Tianjin, China, 300020
Contact: Lei Zhang, MD    +862223909240    zhanglei1@ihcams.ac.cn   
Contact: Lei Zhang    +82223909240    zhanglei1@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Lei Zhang Institute of Hematology & Blood Diseases Hospital
More Information
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Responsible Party: Zhang Lei, MD, Professor/Vice director of Thrombosis &Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04890041    
Other Study ID Numbers: SKX-ITP-001
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
 Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases