ow-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in scleroderma

• Conditions: Systemic Sclerosis; MedDRA version: 6.1Level: PTClassification code 10042953

• Registration Number: EUCTR2007-005322-68-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.SSc as defined above

2.Presence of active interstitial alveolitis as defined above

3.Resistance to conventional immunosuppressive treatment as defined above

4.Age 18-80 years

5.Ability to give an informed consent

6.Use of an acceptable method of birth control (if applicable). Pregnancy will be ruled out before study beginning.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Connective tissue diseases other than SSc

2.Smoking habit

3.Pregnancy or lactation

4.HBV or HCV infection

5.Hepatic Disease (ALT or ALP >1.5 fold above normal levels)

6.Moderate or Severe Renal Failure (creatinina clearance <59ml/min)

7.Severe Heart Failure, with Ejection Fraction ≤35% measured by echocardiography

8.Thyroid disease with clinical evidence of hyperthyroidism or hypothyroidism treated with substitutive therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified