Purpura, Schoenlein-HenochHSPNCT04387942
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
A study testing IL-2 in people with Purpura, Schoenlein-Henoch, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Purpura, Schoenlein-Henoch
- What is being tested?
- IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age <18 years old
- meet the EULAR/PRINTO/PRES for the diagnosis of HSP
- HIV negative;Negative for HBV and HCV.
Who cannot join
- heart failure (cardiac function ≥ grade III NYHA)
- liver insufficiency (upper limit of normal range of transaminase > 2 times)
- renal insufficiency (creatinine clearance ≤30ml/min)
- acute or severe infections such as bacteremia and sepsis
- malignant tumor
- high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month
Show all 9Show fewer
- mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
- Intestinal ischemia or perforated gastrointestinal bleeding requires surgery
- Inability to comply with IL-2 treatment regimen.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.
Read the detailed description
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.For all patients,rhIL-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.
- Conditions
- Purpura, Schoenlein-Henoch
- Being tested
- IL-2
- Keywords
- HSP
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2Drug
Also called Recombinant Human Interleukin-2 for Injection
For all patients,rhIL-2 infusions seven days;recurrent patients was applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Interleukin-2 | Experimental | patients were treated with IL-2. Receives: Drug: IL-2 |
| Traditional therapy | No intervention | patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of immunological responses
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
Measured: day 0,day 7
Secondary outcomes (2)
The value of serum immunoglobulins and complements
Laboratory measures were detected, including,serum total IgE, serum Ig A,serum IgG,serum IgM,C3 and C4.
Measured: day 0,day 7,3 month,6 month
Incidence of adverse drug reactions
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage.
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start14 Jun 2020
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Purpura, Schoenlein-HenochStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang si rui, MD and PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387942
- Sponsor's protocol ID
- 20K012-001
- Acronym
- HSP
- Status last verified
- Aug 2022
- First submitted
- 6 May 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
St John J, Vedak P, Garza-Mayers AC, Hoang MP, Nigwekar SU, Kroshinsky D. Location of skin lesions in Henoch-Schonlein purpura and its association with significant renal involvement. J Am Acad Dermatol. 2018 Jan;78(1):115-120. doi: 10.1016/j.jaad.2017.04.1122.
PubMed 29241772Jen HY, Chuang YH, Lin SC, Chiang BL, Yang YH. Increased serum interleukin-17 and peripheral Th17 cells in children with acute Henoch-Schonlein purpura. Pediatr Allergy Immunol. 2011 Dec;22(8):862-8. doi: 10.1111/j.1399-3038.2011.01198.x. Epub 2011 Sep 19.
PubMed 21929599Fontenot JD, Rasmussen JP, Gavin MA, Rudensky AY. A function for interleukin 2 in Foxp3-expressing regulatory T cells. Nat Immunol. 2005 Nov;6(11):1142-51. doi: 10.1038/ni1263. Epub 2005 Oct 16.
PubMed 16227984Ross SH, Cantrell DA. Signaling and Function of Interleukin-2 in T Lymphocytes. Annu Rev Immunol. 2018 Apr 26;36:411-433. doi: 10.1146/annurev-immunol-042617-053352.
PubMed 29677473
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
- ClinicalTrials.gov ID
- NCT04387942
- Acronym / sponsor ID
- HSP / 20K012-001
- Conditions
- Purpura, Schoenlein-Henoch
- Keywords
- HSP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 May 2020 (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.
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.
Detailed description
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.For all patients,rhIL-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Interleukin-2 | Experimental | Drug: IL-2patients were treated with IL-2. |
| Traditional therapy | No intervention | –patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age <18 years old
- meet the EULAR/PRINTO/PRES for the diagnosis of HSP
- HIV negative;Negative for HBV and HCV.
Key exclusion criteria (9 listed)
- heart failure (cardiac function ≥ grade III NYHA)
- liver insufficiency (upper limit of normal range of transaminase > 2 times)
- renal insufficiency (creatinine clearance ≤30ml/min)
- acute or severe infections such as bacteremia and sepsis
- malignant tumor
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 |
|---|---|---|
| IL-2Also: Recombinant Human Interleukin-2 for InjectionFor all patients,rhIL-2 infusions seven days;recurrent patients was applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months. | Drug | Recombinant Human Interleukin-2 |
Primary outcome
The change of immunological responses
Time frame: day 0,day 7
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
2 secondary outcomes
The value of serum immunoglobulins and complements
Time frame: day 0,day 7,3 month,6 month
Incidence of adverse drug reactions
Time frame: up to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 29241772St John J, Vedak P, Garza-Mayers AC, Hoang MP, Nigwekar SU, Kroshinsky D. Location of skin lesions in Henoch-Schonlein purpura and its association with significant renal involvement. J Am Acad Dermatol. 2018 Jan;78(1):115-120. doi: 10.1016/j.jaad.2017.04.1122.
- Background: PubMed 21929599Jen HY, Chuang YH, Lin SC, Chiang BL, Yang YH. Increased serum interleukin-17 and peripheral Th17 cells in children with acute Henoch-Schonlein purpura. Pediatr Allergy Immunol. 2011 Dec;22(8):862-8. doi: 10.1111/j.1399-3038.2011.01198.x. Epub 2011 Sep 19.
- Background: PubMed 16227984Fontenot JD, Rasmussen JP, Gavin MA, Rudensky AY. A function for interleukin 2 in Foxp3-expressing regulatory T cells. Nat Immunol. 2005 Nov;6(11):1142-51. doi: 10.1038/ni1263. Epub 2005 Oct 16.
- Background: PubMed 29677473Ross SH, Cantrell DA. Signaling and Function of Interleukin-2 in T Lymphocytes. Annu Rev Immunol. 2018 Apr 26;36:411-433. doi: 10.1146/annurev-immunol-042617-053352.
- 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.
Yang si rui, MD and PhD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IL-2 in people with Purpura, Schoenlein-Henoch, run by The First Hospital of Jilin University 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 18 Aug 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change of immunological responses (time frame: day 0,day 7). 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 NCT04387942, which also lists 4 linked publications.
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 18 Aug 2022.