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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03365869 |
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Date of registration:
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04/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
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Scientific title:
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A Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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72 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03365869 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 2
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Contacts
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Name:
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Wuri Liga, Master |
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Address:
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Telephone:
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+8618801231167 |
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Email:
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murongster@163.com |
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Affiliation:
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Name:
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Mu Rong, Poster |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University Institute of Rheumatology and Immunology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meet the American College of Rheumatology criteria for the diagnosis of SSc, 2013.
- Disease duration less than 5 years.
- mRSS was under stable level (>1 month) at the time inclusion.
- Negative urine pregnancy test
- Written informed consent form
Exclusion Criteria:
- Diagnosed with localized scleroderma .
- Added with immunosuppressor in one month such as MTX, AZA, CYC.
- Added with anti-fibosis drug in one month.
- Prednisone >10mg QD before inclusion.
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (= grade III
NYHA), hepatic insufficiency (transaminases> 3N) )
- Serious infection such as bacteremia, sepsis
- Mental disorder or any other chronic illness or drug-abuse that could interfere with
the ability to comply with the protocol or to give information
- Cancer or history of cancer cured for less than five years (except in situ carcinoma
of the cervix or Basocellular carcinoma)
- Positive HIV test
- Positive urine pregnancy test
- Combined with the other connective tissue diseases
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Number of participants whose modified Rodnan skin score (mRSS)decreasing
[Time Frame: week 48]
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Secondary Outcome(s)
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The number of adverse event and severe adverse event occured
[Time Frame: week 48]
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Secondary ID(s)
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PKUPH-R-SRL
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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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