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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: |
NCT00501995 |
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Date of registration:
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13/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Dose Cyclophosphamide for Treatment of Scleroderma
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Scientific title:
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High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) |
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Date of first enrolment:
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February 2001 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00501995 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Fredrick M Wigley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meet established criteria for a diagnosis of diffuse cutaneous scleroderma and have
evidence of moderately severe organ damage and clinical evidence of active disease.
- Patients with diffuse scleroderma who have evidence of active fibrosing alveolitis
manifested by either a greater than 10% decline in the forced vital capacity or the
diffusing capacity from the defined normal values or from baseline measurements.
- Patients with severe deforming localized scleroderma (generalized morphea, liner
morphea, keloid or bullous scleroderma) that threatens their capacity to function
normally in society.
Exclusion Criteria:
- Age less than 18 years and over 70 years
- Any risk of pregnancy
- Cardiac ejection fraction of < 45%
- Serum creatinine > 3.0
- Patients who are pre-terminal or moribund
- Bilirubin > 2.0, transaminases > 2x normal
- Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), (5/30/01) <
50% predicted
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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Scleroderma
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Intervention(s)
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Drug: IV Cyclophosphamide
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Primary Outcome(s)
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Improvement in the Modified Rodnan Skin Score.
[Time Frame: 0 to 24 months]
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Secondary Outcome(s)
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Change in the HAQ-DI, PGA, FVC and DLCO
[Time Frame: 0-24 months]
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Secondary ID(s)
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00-11-17-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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