Henoch-Schönlein PurpuraNCT03647852
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
A study testing Methylprednisolone, IVIG and other basic supportive treatment in people with Henoch-Schönlein Purpura, run by Children's Hospital of Fudan University at 3 sites in China.
Trial summary
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Henoch-Schönlein Purpura
- What is being tested?
- Methylprednisolone, IVIG and other basic supportive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2019to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- both genders
- age between 2-16 years old
- IgA vasculitis with gastrointestinal involvement
- course of disease less than 2 months
- refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）
Who cannot join
- patients with severe sepsis
- patients with central nervous system infection,
- patients with severe pneumonia
- patients with chronic infection (such as EBV, CMV, Tuberculosis)
- patients complicated by CKD who need renal replacement therapy
- patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai
Li Sun, MD
- Not yet recruiting
Children's Hospital of Shanghai
Shanghai
Wenyan Huang, MD
- Not yet recruiting
Shanghai Children's Medical Centre
Shanghai
Wei Zhou, MD
About this study
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
- Conditions
- Henoch-Schönlein Purpura
- Being tested
- Methylprednisolone, IVIG, other basic supportive treatment
- Keywords
- severe gastrointestinal involvement
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
IVIGDrug
- IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
other basic supportive treatmentDrug
- Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day
- Low molecular weight heparin calcium 50IU/kg.d
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone group | Experimental | In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d) Receives: Drug: Methylprednisolone; Drug: other basic supportive treatment |
| IVIG group | Active comparator | In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d) Receives: Drug: IVIG; Drug: other basic supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained abdominal pain relief
no abdominal pain complaint and no abdominal tenderness
Measured: 3 days after treatment
Secondary outcomes (11)
sustained abdominal pain relief
3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment
Measured: 7 days after treatment
other treatment rather than assigned intervention
other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
Measured: 4 weeks after treatment
tolarable food type
what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
Measured: 2 weeks after treatment
the number of days of taking fasting
the number of days of taking fasting will be counted at the time of discharge
Measured: At the time of discharge
Drug-related side effects
Side effects associated with methylprednisolone and IVIG will be recorded
Measured: 3 days after treatment
hypertension
systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.
Measured: 7 days after treatment
infection
different infection types should be specified
Measured: 4 weeks after treatment
ocular hypertension
1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg
Measured: 7 days after treatment
steroid-related diabetes
- with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l
Measured: 3 days after treatment
cost of treatment
cost of treatment will be obtained from discharge fee list
Measured: 4 weeks after treatment
The number of days in hospital
The number of days in hospital will be counted at the time of discharge
Measured: at the time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Sep 2019
- Primary completion27 Feb 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Henoch-Schönlein PurpuraStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Li Sun, MD, Principal investigator, Children's Hospital of Fudan UniversityWenyan Huang, MD, Principal investigator, Shanghai Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647852
- Sponsor's protocol ID
- chfuHSP 1.0
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2018
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
- ClinicalTrials.gov ID
- NCT03647852
- Acronym / sponsor ID
- chfuHSP 1.0
- Conditions
- Henoch-Schönlein Purpura
- Keywords
- severe gastrointestinal involvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Aug 2018 (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.
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone group | Experimental | Drug: Methylprednisolone, Drug: other basic supportive treatmentIn this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d) |
| IVIG group | Active comparator | Drug: IVIG, Drug: other basic supportive treatmentIn this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d) |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- both genders
- age between 2-16 years old
- IgA vasculitis with gastrointestinal involvement
- course of disease less than 2 months
- refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）
Key exclusion criteria (6 listed)
- patients with severe sepsis
- patients with central nervous system infection,
- patients with severe pneumonia
- patients with chronic infection (such as EBV, CMV, Tuberculosis)
- patients complicated by CKD who need renal replacement therapy
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 |
|---|---|---|
| Methylprednisolone1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change | Drug | Methylprednisolone group |
| IVIG1. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days | Drug | IVIG group |
| other basic supportive treatment1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d | Drug | IVIG group, Methylprednisolone group |
Primary outcome
sustained abdominal pain relief
Time frame: 3 days after treatment
no abdominal pain complaint and no abdominal tenderness
11 secondary outcomes
sustained abdominal pain relief
Time frame: 7 days after treatment
other treatment rather than assigned intervention
Time frame: 4 weeks after treatment
tolarable food type
Time frame: 2 weeks after treatment
the number of days of taking fasting
Time frame: At the time of discharge
Drug-related side effects
Time frame: 3 days after treatment
hypertension
Time frame: 7 days after treatment
infection
Time frame: 4 weeks after treatment
ocular hypertension
Time frame: 7 days after treatment
steroid-related diabetes
Time frame: 3 days after treatment
cost of treatment
Time frame: 4 weeks after treatment
The number of days in hospital
Time frame: at the time of discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Yes
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A Randomized Multicenter Study for Isolated Skin Vasculitis
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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.
Li Sun, MD principal investigator
Children's Hospital of Fudan University
Wenyan Huang, MD principal investigator
Shanghai Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone, IVIG and other basic supportive treatment in people with Henoch-Schönlein Purpura, run by Children's Hospital of Fudan University at 3 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Sun, MD (+8618017590930, lillysun@263.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained abdominal pain relief (time frame: 3 days 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 19 Feb 2025.