Immune ThrombocytopeniaPhase 4ITPNCT03201848
The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia
A Phase 4 study testing Huaiqihuang Granule in people with Immune Thrombocytopenia, run by Qidong Gaitianli Medicines Co., Ltd at 14 sites in China.
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). Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Huaiqihuang Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 14 sitesChina
- Study dates
- 16 Nov 2017to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Beijing Children's Hospital. Capital Medical University
Beijing
Children's Hospital Capital Institute of Pediatrics
Beijing
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Children's Hospital of Soochow University
Suzhou, Jiangsu
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Union Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430022
Wuhan Children's Hospital
Wuhan, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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)
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).
Read the 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).
- Conditions
- Immune Thrombocytopenia
- Being tested
- Placebo, Huaiqihuang Granule
- Keywords
- Huaiqihuang granule, immune thrombocytopenia, randomized, double-blind, placebo-controlled,
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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 GranuleDrug
Also called Huaiqihuang
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)
| Study group | Role | What they receive |
|---|---|---|
| Huaiqihuang Granule | Experimental | Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks Receives: 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. Receives: Drug: Placebo; Drug: Huaiqihuang Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24、48 and 60 Weeks after treatment
Secondary outcomes (2)
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.
Measured: 24、48 and 60 Weeks after treatment
the recovery rate of thyroid function
The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.
Measured: 12、24、36、48、60 and 72 Weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start16 Nov 2017
- Primary completion14 Oct 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Runming Jin, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201848
- Sponsor's protocol ID
- HQH-201703.01
- Acronym
- ITP
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03201848
- Acronym / sponsor ID
- ITP / HQH-201703.01
- Conditions
- Immune Thrombocytopenia
- Keywords
- Huaiqihuang granule, immune thrombocytopenia, randomized, double-blind, placebo-controlled,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Qidong Gaitianli Medicines Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Huazhong University of Science and Technology
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 14 Oct 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaiqihuang Granule | Experimental | Drug: Huaiqihuang GranuleHuaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Huaiqihuang GranulePlacebo given to subject will be adjusted by body weight After 24 weeks of placebo, change to Huaiqihuang Granule for another 24 weeks. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo 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 | Placebo |
| Huaiqihuang GranuleAlso: HuaiqihuangHuaiqihuang 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) | Drug | Huaiqihuang Granule, Placebo |
Primary outcome
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.
2 secondary outcomes
the recovery rate of immune function
Time frame: 24、48 and 60 Weeks after treatment
the recovery rate of thyroid function
Time frame: 12、24、36、48、60 and 72 Weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Runming Jin, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaiqihuang Granule in people with Immune Thrombocytopenia, run by Qidong Gaitianli Medicines Co., Ltd at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of subjects whose hemorrhage has improved (clinical effective rate) (time frame: 24、48 and 60 Weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.