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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenia	Drug: Placebo; Drug: Huaiqihuang Granule	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	216 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Actual Study Start Date :	June 28, 2017
Estimated Primary Completion Date :	December 31, 2020
Estimated Study Completion Date :	December 31, 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Huaiqihuang Granule; Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks	Drug: 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); Other Name: Huaiqihuang
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.	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;) .; Drug: 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); Other Name: Huaiqihuang

Outcome Measures

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Primary Outcome Measures :

1. the proportion of subjects whose hemorrhage has improved (clinical effective rate) [ Time Frame: 24、48 and 60 Weeks after treatment ]

   The improvement of hemorrhage is defined if at least one of the following criteria is met:

   1. 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.).
   2. 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).
   3. The score of quality of life improves one or more points.

Secondary Outcome Measures :

1. the recovery rate of immune function [ Time Frame: 24、48 and 60 Weeks after treatment ]
   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.
2. the recovery rate of thyroid function [ Time Frame: 12、24、36、48、60 and 72 Weeks after treatment ]
   The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.

Eligibility Criteria

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Ages Eligible for Study:	1 Year to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Yonghui Lu, Ph.D	+0086-13801462500	lyh307@sina.com

Locations

China, Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science & Technology	Recruiting
Wuhan, Hubei, China, 430022
Contact: runming jin, Professor +0086-13037111958 jinrunm@qq.com

Sponsors and Collaborators

Qidong Gaitianli Medicines Co., Ltd

Huazhong University of Science and Technology

Investigators

Principal Investigator:	Runming Jin, Professor	Union Hospital of Tongji Medical College, Huazhong University of Science & Technology

More Information

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Responsible Party:	Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier:	NCT03201848 History of Changes
Other Study ID Numbers:	HQH-201703.01
First Posted:	June 28, 2017
Last Update Posted:	July 14, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Qidong Gaitianli Medicines Co., Ltd:

Huaiqihuang granule; immune thrombocytopenia; randomized; double-blind; placebo-controlled,

Additional relevant MeSH terms:

Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Blood Platelet Disorders; Hematologic Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies	Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Signs and Symptoms