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

NCT03201848 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: HQH-201703.01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 14

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).

Conditions

Immune Thrombocytopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  24、48 and 60 Weeks after treatment

Secondary Outcomes (2)

• the recovery rate of immune function

  24、48 and 60 Weeks after treatment

• the recovery rate of thyroid function

  12、24、36、48、60 and 72 Weeks after treatment

Study Arms (2)

Huaiqihuang Granule

EXPERIMENTAL

Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks

Drug: Huaiqihuang Granule

Placebo

PLACEBO COMPARATOR

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; Drug: Huaiqihuang Granule

Interventions

Placebo DRUG

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;) .

Placebo

Huaiqihuang Granule DRUG

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)

Also known as: Huaiqihuang

Huaiqihuang Granule; Placebo

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qidong Gaitianli Medicines Co., Ltd: lead
• Huazhong University of Science and Technology: collaborator

Study Sites (14)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430022, China

Location

Wuhan Children's Hospital

Wuhan, Hubei, China

Location

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Beijing Children's Hospital. Capital Medical University

Beijing, China

Location

Children's Hospital Capital Institute of Pediatrics

Beijing, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

huai qi huang

Condition Hierarchy (Ancestors)

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

Study Officials

• Runming Jin, Professor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: November 16, 2017
• Primary Completion: October 14, 2023
• Study Completion: June 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)