- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03201848
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (ITP)
A Multisite, Randomized, Double-Blind, Placebo-Controlled, and Parallel Study to Evaluate the Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (Qi Yin Deficiency)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The randomized clinical trial included subjects (n =216) will be randomly divided into experimental (n = 162) and control groups (n =54) according to a random number table. Patients in the experimental group will receive Huaiqihuang Granule . Patients in the control group will receive placebo a placebo-controlled designed is used for this study. To minimize the risks, treatment stopping rules and subsequent measures are established for subjects whose disease under study become worsening during the study. Subjects receiving placebo treatment will switch to investigational drug after Week 24 to reduce the risk of lack of efficacy by placebo.
The primary outcome measures is proportion of patients whose hemorrhage has improved (clinical effective rate).
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yonghui Lu, Ph.D
- Phone Number: +0086-13801462500
- Email: lyh307@sina.com
Study Locations
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Beijing, China
- Children's Hospital Capital Institute of Pediatrics
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Beijing, China
- Beijing Children's Hospital. Capital Medical University
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Shanghai, China
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Guangdong
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Guangzhou, Guangdong, China
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Guangdong, China
- Guangzhou women and children's medical center
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Henan
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Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China
- Wuhan Children's Hospital
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Wuhan, Hubei, China, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science & Technology
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Jiangsu
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Nanjing, Jiangsu, China
- Children's Hospital of Nanjing Medical University
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Suzhou, Jiangsu, China
- Children's Hospital of Soochow University
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Jiangxi
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Nanchang, Jiangxi, China
- Jiangxi Provincial Children's Hospital
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Shandong
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Qingdao, Shandong, China
- The Affiliated Hospital of Qingdao University
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Sichuan
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Luzhou, Sichuan, China
- The Affiliated Hospital of Southwest Medical University
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Xinjiang
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Ürümqi, Xinjiang, China
- First Affiliated Hospital of Xinjiang Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged between 1 and 14 years (inclusive) ;
- Is diagnosed as immune thrombocytopenia according to the criteria of ICD-10, i.e., platelet < 100×109/L for at least two hematology tests with normal blood cell morphology; skin petechia, ecchymosis and (or) the clinical manifestations of mucosa and visceral hemorrhage; no splenomegaly; exclusion of other secondary thrombocytopenia, such as aplastic leukemia, aplastic anemia characterized by thrombocytopenia as the first hematologic abnormality, hereditary thrombocytopenia, thrombocytopenia secondary to other autoimmune diseases, infections or drugs etc...
- Meet the diagnosis criteria for Qi Yin deficiency in traditional Chinese medicine;
- Time since initial diagnosis of ITP until randomization is at least 12 month, i.e., course of disease ≥1 year;
- Values of prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) are within 1.2 times of normal reference range;
- Values of biochemistry parameters including creatinine, ALT, AST, glucose, total bilirubin are less than 1.2 time of the corresponding upper limit of normal range;
- Has signed and dated the informed consent in volunteer by the subject and the subject's legal guardian(s) (for subject who is less than 8 years old, the informed consent will be signed and dated by the subject's legal guardian(s) in volunteer).
Exclusion Criteria:
- Is diagnosed as congenital thrombocytopenia;
- Is diagnosed as secondary thrombocytopenia;
- Is diagnosed as non-immune thrombocytopenia;
- Has medical history of diabetes;
- In the judgement of Investigator, the subject is not appropriate to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Huaiqihuang Granule
Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks
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Huaiqihuang Granule given to subject will be adjusted by body weight (<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day)
Other Names:
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Placebo Comparator: Placebo
Placebo given to subject will be adjusted by body weight After 24 weeks of placebo, change to Huaiqihuang Granule for another 24 weeks.
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Huaiqihuang Granule given to subject will be adjusted by body weight (<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day)
Other Names:
Placebo given to subject will be adjusted by body weight (<10kg, Placebo given to subject will be adjusted by body weight(<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day;) .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the proportion of subjects whose hemorrhage has improved (clinical effective rate)
Time Frame: 24、48 and 60 Weeks after treatment
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The improvement of hemorrhage is defined if at least one of the following criteria is met:
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24、48 and 60 Weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the recovery rate of immune function
Time Frame: 24、48 and 60 Weeks after treatment
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The recovery rate of immune function is the proportion of subjects who have normalized immune function after treatment.
The parameters of immune function include cytokines, lymphocyte subsets and auto immunity.
One of the three tests has been restored to normal is defined as the immune function has returned to normal.
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24、48 and 60 Weeks after treatment
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the recovery rate of thyroid function
Time Frame: 12、24、36、48、60 and 72 Weeks after treatment
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The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.
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12、24、36、48、60 and 72 Weeks after treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Runming Jin, Professor, Wuhan Union Hospital, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- HQH-201703.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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