Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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4 March 2024 |
Main ID: |
NCT04077736 |
Date of registration:
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01/09/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Low-dose Recombinant Human IL-2 for the Treatment of Relapsing Polychondritis
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Scientific title:
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A Pilot Study of Low Dose IL-2 in the Treatment of Relapsing Polychondritis |
Date of first enrolment:
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November 1, 2019 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT04077736 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Li Zhanguo |
Address:
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Telephone:
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Email:
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Affiliation:
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Peking University Institute of Rheuamotology and Immunology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female =18 and =70 years
2. Meet the revised Michet criteria
3. Patients had an inadequate response to standard treatment for = 4 weeks. The
background treatment included corticosteroids (=0.5 mg/ kg), immunosuppressants (
methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil leflunomide, or
cyclophosphamide)
4. Negative urine pregnancy test
5. Written informed consent form
Exclusion Criteria:
- Any subject who meets any of the following criteria shall be excluded:
1. Use rituximab or other monoclonal antibodies within 1.6 months.
2. 1 months after treatment with high dose glucocorticoid (> 1 mg/kg/d).
3. Serious complications: heart failure (= New York Heart Association(NYHA) III
grade), renal insufficiency (creatinine clearance rate = 30 ml/min), liver
function insufficiency (serum alanine transaminase or glutamic-pyruvic
transaminaseT > 3 times normal upper limit, or total bilirubin > normal upper
limit)
4. Other serious, progressive or uncontrollable hematological, gastrointestinal,
endocrine, lung, heart, nerve, or brain diseases (including demyelination
diseases, such as multiple sclerosis).
5. Known allergies, hyperresponsiveness or IL-2 or its excipients are intolerant.
6. Severe infections (including, but not limited to, hepatitis, pneumonia,
bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection),
hospitalization for infection, or intravenous antibiotics 2 months before the
first dose of treatment.
7. Chest imaging showed abnormalities in malignant tumors or current active
infections (including tuberculosis) within 3 months before the first use of the
study.
8. Infected with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody
positive serology). If seropositive, consult a doctor with expertise in the
treatment of HIV or hepatitis C virus infection.
9. There has been any known malignant tumor or history of malignant tumor in the
past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin
cancer with no sign of recurrence or surgically cured cervical tumor within 3
months of use of the first study preparation).
10. There are uncontrolled mental or emotional disorders, including a history of drug
and alcohol abuse over the past three years, which may hinder the successful
completion of the study.
11. Within 3 months before the first injection of the research agent, during the
study period or within 4 months after the last injection of the research agent,
any live virus or bacterial vaccine is received or expected to be received.
Bacillus Calmette-Guerin was vaccinated within 12 months after screening.
12. Pregnant and lactating women (WCBP) are reluctant to use medically approved
contraceptives during and 12 months after treatment.
13. Men whose partners have fertility potential but do not want to use appropriate
medically approved contraceptives during and within 12 months of treatment.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Polychondritis
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Intervention(s)
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Drug: Interleukin-2
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Primary Outcome(s)
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Foxp3+Treg cells: change in percentage of total lymphocytes
[Time Frame: week 12]
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Secondary Outcome(s)
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Relapsing Polychondritis Disease Activity Index
[Time Frame: week 12]
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safety assessment
[Time Frame: week 12]
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Secondary ID(s)
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2019PHB089-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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