The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-14

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura

NCT01104428

Purpura, Schoenlein-Henoch

UNKNOWN PHASE2

Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)

NCT06838962

Immune Thrombocytopenia Treatment

RECRUITING PHASE2

Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

NCT02317133

Henoch Schönlein Purpura

COMPLETED

Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

NCT04737850

Immune Thrombocytopenia

COMPLETED PHASE3

Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)

NCT03123497

Idiopathic Thrombocytopenic Purpura

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Purpura, Schoenlein-Henoch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

group A:patients were treated with IL-2.group B:patients were not treated with IL-2.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recombinant Human Interleukin-2

patients were treated with IL-2.

Group Type EXPERIMENTAL

IL-2

Intervention Type DRUG

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.

Traditional therapy

patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IL-2

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Recombinant Human Interleukin-2 for Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. age \<18 years old
2. meet the EULAR/PRINTO/PRES for the diagnosis of HSP
3. HIV negative;Negative for HBV and HCV.

Exclusion Criteria

1. heart failure (cardiac function ≥ grade III NYHA)
2. liver insufficiency (upper limit of normal range of transaminase \> 2 times)
3. renal insufficiency (creatinine clearance ≤30ml/min)
4. acute or severe infections such as bacteremia and sepsis
5. malignant tumor
6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month
7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
8. Intestinal ischemia or perforated gastrointestinal bleeding requires surgery
9. Inability to comply with IL-2 treatment regimen.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes