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Trial record 8 of 66 for:    Recruiting Studies | immune thrombocytopenia

Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

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. Identifier: NCT04737850
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : August 30, 2022
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the efficacy, safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age. This is a 2 part study. In part A, patients will receive Hetrombopag for 8 weeks. In part B, all patients will receive Hetrombopag for 24 weeks.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Hetrombopag Drug: Placebo Phase 3

Detailed Description:
This is a two-part, double-blind, randomized, placebo-controlled, and open-label Phase III study to investigate the efficacy, safety of Hetrombopag in pediatric patients with previously treated chronic ITP. In Part A, patients will receive Hetrombopag for 8 weeks. After completing Part A, patients will begin Part B, in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind, placebo-controlled treatment period, following an open-label 12 week treatment period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia:a Randomized, Multicenter, Placebo-controlled Trial
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: PartA, open-label
Hetrombopag plus standard of care
Drug: Hetrombopag
Thrombopoietin receptor agonist

Experimental: PartB, double-blind treatment group
Hetrombopag plus standard of care
Drug: Hetrombopag
Thrombopoietin receptor agonist

Placebo Comparator: Placebo Comparator
Placebo plus standard of care Part B, double-blind treatment group
Drug: Placebo
Placebo with no active pharmaceutical ingredient

Primary Outcome Measures :
  1. the main parameters in population PK/PD modeling in Part A [ Time Frame: from baseline to Week 2 ]
    Peak Plasma Concentration (Cmax)

  2. the proportion of patients with a platelet count ≥50×10^9/L at week 10. [ Time Frame: from baseline to Week 10 ]
    efficacy in part B

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 6 years old and ≤ 17 years old,both sexes.
  2. Part A:Confirmed diagnosis of ITP ≥6months; Part B: Confirmed diagnosis of ITP ≥12months;Platelets <30×10^9/L twice in a row,and platelets <30×10^9/L before taking the medicine.
  3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
  4. Birth control during and 28 days after the trial.
  5. Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 8 years old).

Exclusion Criteria:

  1. No evidence of other causes of thrombocytopenia.
  2. Diagnosis as Evans or Wiskott-Aldrich comprehensive.
  3. Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.
  4. Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.
  5. ALT, AST, or ALP> 1.5 x upper limit of normal (ULN), DBLI, or Scr > 1.2 x upper limit of normal (ULN).
  6. Active HIV or HCV-Ab positive,HBsAg positive.
  7. PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
  8. Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.
  9. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.

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 identifier (NCT number): NCT04737850

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Contact: Tianyou Wang, Ph.D 010-59616161

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China, Beijing
Beijing children's hospital .Capital medical university Recruiting
Beijing, Beijing, China, 100032
Contact: Tianyou Wang, PhD   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT04737850    
Other Study ID Numbers: HR-TPO-ITP-III-PED
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Additional relevant MeSH terms:
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Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Pathologic Processes
Skin Manifestations