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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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19 February 2015 |
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Main ID: |
NCT00573326 |
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Date of registration:
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13/12/2007 |
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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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Low-Dose Oral Imatinib for Scleroderma Pulmonary Involvement
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Scientific title:
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Low-Dose Oral Imatinib in the Treatment of Scleroderma Pulmonary Involvement: A Phase II Pilot Study |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00573326 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Paolo Fraticelli, Dr |
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Address:
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Telephone:
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+390715964256 |
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Email:
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p.fraticelli@ospedaliriuniti.marche.it |
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Affiliation:
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Name:
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Paolo Fraticelli, Dr |
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Address:
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Telephone:
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+390715964256 |
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Email:
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p.fraticelli@ospedaliriuniti.marche.it |
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Affiliation:
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Name:
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Armando Gabrielli, 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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Università Politecnica delle Marche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SSc with active pulmonary involvement refractory to conventional immunosuppressive
regimen
- Presence of active interstitial alveolitis (presence of grade 2 exertional dyspnea
according to Mahler Dyspnea Index AND worsening of lung function tests PLUS
interstitial alveolitis assessed by HRCTscan, ground-glass pattern involving at least
two lung segments OR dyspnea (as defined above)PLUS Interstitial alveolitis assessed
by HRCTscan (AS DEFINED ABOVE) AND neutrophilic or eosinophilic alveolitis detected
through broncoalveolar lavage
- Resistance to conventional immunosuppressive treatment (worsening or lack of
improvement of lung function tests after cyclophosphamide therapy, conducted for at
least three months, with a cumulative dosage > or = 6 g
- Age 18-80 years
- Ability ti give an informed consent
- Use of an acceptable method of birth control; pregnancy will be ruled out before
study beginning
Exclusion Criteria:
- Connective tissue diseases other than SSc
- Smoking Habit
- Pregnancy or lactation
- HBV or HCV infection
- Severe anaemia (Hb< or = 8g/dl)
- Hepatic disease (ALT or ALP>1.5 fold above normal levels)
- Moderate or severe renal failure (creatinine clearance<59ml/min)
- Severe heart failure, with ejection fraction < or = 35% measured by echocardiography
- thyroid disease with clinical evidence of hyperthyroidism treated with substitutive
therapy
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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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: Imatinib
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Primary Outcome(s)
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Improvement of the pulmonary interstitial disease, evaluated by spirometry and DLCO, lung HRCTscan, emogasanalysis.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Cutaneous Involvement, evaluated by the modified Rodnan skin score; quality of life and patient physical and emotional well being, evaluated by SF-36 score and HAQ
[Time Frame: 1 year]
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Secondary ID(s)
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FARM 69J AJ9
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EudraCT code:2007-005322-68
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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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