- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737850
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
August 26, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia:a Randomized, Multicenter, Placebo-controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
117
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tianyou Wang, Ph.D
- Phone Number: 010-59616161
- Email: wangtianyou@bch.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100032
- Recruiting
- Beijing children's hospital .Capital medical university
-
Contact:
- Tianyou Wang, PhD
- Email: wangtianyou@bch.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 6 years old and ≤ 17 years old,both sexes.
- 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.
- Subjects who are refractory or have relapsed after at least one prior ITP therapy.
- Birth control during and 28 days after the trial.
- 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:
- No evidence of other causes of thrombocytopenia.
- Diagnosis as Evans or Wiskott-Aldrich comprehensive.
- Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.
- Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.
- ALT, AST, or ALP> 1.5 x upper limit of normal (ULN), DBLI, or Scr > 1.2 x upper limit of normal (ULN).
- Active HIV or HCV-Ab positive,HBsAg positive.
- PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
- Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PartA, open-label
Hetrombopag plus standard of care
|
Thrombopoietin receptor agonist
|
Experimental: PartB, double-blind treatment group
Hetrombopag plus standard of care
|
Thrombopoietin receptor agonist
|
Placebo Comparator: Placebo Comparator
Placebo plus standard of care Part B, double-blind treatment group
|
Placebo with no active pharmaceutical ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the main parameters in population PK/PD modeling in Part A
Time Frame: from baseline to Week 2
|
Peak Plasma Concentration (Cmax)
|
from baseline to Week 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
|
from baseline to Week 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
January 17, 2021
First Submitted That Met QC Criteria
February 3, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- HR-TPO-ITP-III-PED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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