Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc

• Conditions: Systemic Scleroderma; MedDRA version: 9.1Level: LLTClassification code 10055953Term: Scleroedema

• Registration Number: EUCTR2006-003957-25-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: 2007-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

a. edSSc (ACR criteria);

b. age 18-80 years;

c. ability to give an informed consent;

d. use of an acceptable method of birth control (if women in childbearing age).
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

a. connective tissue diseases other than SSc;

b. history of intolerance to the study drugs;

c. severe cardiac failure (NYHA >=3 or left ventricular ejection fraction <40%), recent (<6 months) history of myocardial

infarction; symptomatic ischemic myocardial disease, ventricular tachyarrhythmia, atrial fibrillation;

d. resting PaO2 <60mm/hg or Carbon Monoxide Diffusing Capacity <40% of predicted

e. creatinina clearance below 90ml/h

f. ALT or bilirubin above two times upper normal limits;

g. bronchial asthma;

h. hemorrhagic diathesis

Study & Design

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