Back to resultsThe Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (ITP)
Primary Purpose
Immune Thrombocytopenia
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Placebo
Huaiqihuang Granule
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Huaiqihuang granule, immune thrombocytopenia, randomized, double-blind, placebo-controlled,
Eligibility Criteria
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.
Sites / Locations
- Guangzhou Women and Children's Medical Center
- The First Affiliated Hospital, Sun Yat-sen University
- The First Affiliated Hospital of Zhengzhou University
- Union Hospital of Tongji Medical College, Huazhong University of Science & Technology
- Wuhan Children's Hospital
- Children's Hospital of Nanjing Medical University
- Children's Hospital of Soochow University
- Jiangxi Provincial Children's Hospital
- The Affiliated Hospital of Qingdao University
- The Affiliated Hospital of Southwest Medical University
- First Affiliated Hospital of Xinjiang Medical University
- Beijing Children's Hospital. Capital Medical University
- Children's Hospital Capital Institute of Pediatrics
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Huaiqihuang Granule
Placebo
Arm Description
Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks
Placebo given to subject will be adjusted by body weight After 24 weeks of placebo, change to Huaiqihuang Granule for another 24 weeks.
Outcomes
Primary Outcome Measures
the proportion of subjects whose hemorrhage has improved (clinical effective rate)
The improvement of hemorrhage is defined if at least one of the following criteria is met:
Severity of hemorrhage decreases one or more grade, the severity of hemorrhage is defined as following: none: there is any hemorrhage manifestation; mild: simple (often related with an unnoticeable minor collision without obvious ecchymosis) or obvious ecchymosis by collision; moderate: mucous membrane hemorrhage (nose hemorrhage, gum, oral mucosa) and menorrhagia; and severe: organ hemorrhage (digestive tract, respiratory tract, intracranial, etc.).
Significant increase in platelet count defined as platelet count is over 30×109/L and increases more than twice compared with the baseline. The results must be tested at least twice with at least 7 days apart).
The score of quality of life improves one or more points.
Secondary Outcome Measures
the recovery rate of immune function
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.
the recovery rate of thyroid function
The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.
Full Information
NCT ID
NCT03201848
First Posted
June 27, 2017
Last Updated
October 23, 2023
Sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03201848
Brief Title
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia
Acronym
ITP
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
October 10, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qidong Gaitianli Medicines Co., Ltd
Collaborators
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multisite, double-blind, randomized, placebo-controlled, and parallel study designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to children with chronic primary immune thrombocytopenia (Qi Yin deficiency).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Huaiqihuang granule, immune thrombocytopenia, randomized, double-blind, placebo-controlled,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Huaiqihuang Granule
Arm Type
Experimental
Arm Description
Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given to subject will be adjusted by body weight After 24 weeks of placebo, change to Huaiqihuang Granule for another 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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;) .
Intervention Type
Drug
Intervention Name(s)
Huaiqihuang Granule
Other Intervention Name(s)
Huaiqihuang
Intervention Description
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)
Primary Outcome Measure Information:
Title
the proportion of subjects whose hemorrhage has improved (clinical effective rate)
Description
The improvement of hemorrhage is defined if at least one of the following criteria is met:
Severity of hemorrhage decreases one or more grade, the severity of hemorrhage is defined as following: none: there is any hemorrhage manifestation; mild: simple (often related with an unnoticeable minor collision without obvious ecchymosis) or obvious ecchymosis by collision; moderate: mucous membrane hemorrhage (nose hemorrhage, gum, oral mucosa) and menorrhagia; and severe: organ hemorrhage (digestive tract, respiratory tract, intracranial, etc.).
Significant increase in platelet count defined as platelet count is over 30×109/L and increases more than twice compared with the baseline. The results must be tested at least twice with at least 7 days apart).
The score of quality of life improves one or more points.
Time Frame
24、48 and 60 Weeks after treatment
Secondary Outcome Measure Information:
Title
the recovery rate of immune function
Description
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.
Time Frame
24、48 and 60 Weeks after treatment
Title
the recovery rate of thyroid function
Description
The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.
Time Frame
12、24、36、48、60 and 72 Weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runming Jin, Professor
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Wuhan Children's Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Children's Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Provincial Children's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Beijing Children's Hospital. Capital Medical University
City
Beijing
Country
China
Facility Name
Children's Hospital Capital Institute of Pediatrics
City
Beijing
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia
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