Henoch-Schoenlein PurpuraPhase 2NCT02540720
The Research of Standard Diagnosis and Treatment for Severe HSP in Children
A Phase 2 study testing Dexamethasone, Gamma globulin and Hemoperfusion in people with Henoch-Schoenlein Purpura, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Henoch-Schoenlein Purpura
- What is being tested?
- Dexamethasone, Gamma globulin and Hemoperfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Jul 2020
- Phase
- Phase 2
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days
Who cannot join
- The children with congenital diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000
Aihua Zhang, M.D., +8618951769017, bszah@163.com
About this study
Official title: The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
Read the detailed description
Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.
In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.
The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.
- Conditions
- Henoch-Schoenlein Purpura
- Being tested
- Dexamethasone, Gamma globulin, Hemoperfusion
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Gamma globulinDrug
HemoperfusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Dexamethasone 0.5mg/kg.d i.v. Receives: Drug: Dexamethasone |
| group 2 | Experimental | Dexamethasone \& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \& gamma globulin i.v. qd*3d, and the total dose is 2g/kg Receives: Drug: Dexamethasone; Drug: Gamma globulin |
| group 3 | Experimental | Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days Receives: Drug: Dexamethasone; Procedure: Hemoperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Symptoms of Digestive Tract
The stomachache and other symptoms of digestive tract disappear
Measured: 2 weeks
The Symptoms of Joint System
The arthralgia disappears
Measured: 2 weeks
Secondary outcomes (2)
The Skin Rash
The Skin Rash disappears
Measured: 2 weeks
Renal function
There is no damage in kidney.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Henoch-Schoenlein PurpuraStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aihua Zhang, Nanjing Children's Hospital
- Investigators
- Aihua Zhang, M.D., Study chair, Department of Nephrology, Nanjing children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540720
- Sponsor's protocol ID
- Zhai
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
PubMed 36853224
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
- ClinicalTrials.gov ID
- NCT02540720
- Acronym / sponsor ID
- Zhai
- Conditions
- Henoch-Schoenlein Purpura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- 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 study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
Detailed description
Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.
In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.
The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: DexamethasoneDexamethasone 0.5mg/kg.d i.v. |
| group 2 | Experimental | Drug: Dexamethasone, Drug: Gamma globulinDexamethasone \& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \& gamma globulin i.v. qd*3d, and the total dose is 2g/kg |
| group 3 | Experimental | Drug: Dexamethasone, Procedure: HemoperfusionDexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days
Key exclusion criteria (1 listed)
- The children with congenital diseases
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 |
|---|---|---|
| Dexamethasone | Drug | group 1, group 2, group 3 |
| Gamma globulin | Drug | group 2 |
| Hemoperfusion | Procedure or surgery | group 3 |
Primary outcome
The Symptoms of Digestive Tract
Time frame: 2 weeks
The stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System
Time frame: 2 weeks
The arthralgia disappears
2 secondary outcomes
The Skin Rash
Time frame: 2 weeks
Renal function
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 36853224Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
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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.
Aihua Zhang, M.D. study chair
Department of Nephrology, Nanjing children's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, Gamma globulin and Hemoperfusion in people with Henoch-Schoenlein Purpura, run by Nanjing Children's Hospital at 1 site 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 1 inclusion and 1 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Aihua Zhang, M.D. (+8618951769017, bszah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Symptoms of Digestive Tract (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540720, which also lists 1 linked publication.
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 26 Feb 2020.