The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03201848
• Other study ID #: HQH-201703.01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 16, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: June 30, 2024
• Est. primary completion date: October 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

1. Male or female, aged between 1 and 14 years (inclusive) ;

2. 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...

3. Meet the diagnosis criteria for Qi Yin deficiency in traditional Chinese medicine;

4. Time since initial diagnosis of ITP until randomization is at least 12 month, i.e., course of disease =1 year;

5. Values of prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) are within 1.2 times of normal reference range;

6. 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;

7. 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:

1. Is diagnosed as congenital thrombocytopenia;

2. Is diagnosed as secondary thrombocytopenia;

3. Is diagnosed as non-immune thrombocytopenia;

4. Has medical history of diabetes;

5. In the judgement of Investigator, the subject is not appropriate to participate in this study.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Placebo
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;) .
• Huaiqihuang Granule
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)

Locations

Country	Name	City	State
China	Beijing Children's Hospital. Capital Medical University	Beijing
China	Children's Hospital Capital Institute of Pediatrics	Beijing
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Jiangxi Provincial Children's Hospital	Nanchang	Jiangxi
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai
China	Children's Hospital of Soochow University	Suzhou	Jiangsu
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Union Hospital of Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei
China	Wuhan Children's Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd	Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24?48 and 60 Weeks after treatment
Secondary	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.	24?48 and 60 Weeks after treatment
Secondary	the recovery rate of thyroid function	The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.	12?24?36?48?60 and 72 Weeks after treatment