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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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12 December 2020 |
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Main ID: |
NCT03866681 |
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Date of registration:
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28/02/2019 |
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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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Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH
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Scientific title:
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Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory Classic Paroxysmal Nocturnal Hemoglobinuria ,a Prospective Study |
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Date of first enrolment:
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April 1, 2019 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03866681 |
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Study type:
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Interventional |
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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 4
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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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Bing Han, Doctor |
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Address:
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Telephone:
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+86-010-69155760 |
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Email:
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hanbing_li@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 18-70 years
- diagnosed with PNH and no thrombosis
- ineffective, relapsed or intolerant to conventional treatment (eg glucocorticoids, • •
iron, folic acid, androgen, etc.)
- not available for hematopoietic stem cell transplantation
- ECOG=2
- agreed to sign the consent forms
Exclusion Criteria:
- severe heart, liver and kidney dysfunction
- combined with thrombotic complications
- people who are pregnant and breastfeeding
- history of other immunosuppressive agents in recent 3 months
- Patients who are not eligible to participate in this trial due to any reason based • •
• on the consideration of investigator
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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Paroxysmal Nocturnal Hemoglobinuria
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Intervention(s)
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Drug: sirolimus
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Primary Outcome(s)
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Hemoglobin
[Time Frame: 2 years]
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Secondary Outcome(s)
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Short Form 36 items(SF-36) questionnaire
[Time Frame: 2 years]
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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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