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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003957-25-IT
• Date of registration: 09/07/2007
• Prospective Registration: No
• Primary sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
• Public title: Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc
• Scientific title: Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc
• Date of first enrolment: 13/10/2006
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003957-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Scleroderma
MedDRA version: 9.1 Level: LLT Classification code 10055953 Term: Scleroedema

Intervention(s)

Trade Name: HIDONAC*EV 1FL 5G 25ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Iloprost
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .05-

Primary Outcome(s)

Primary end point(s): The primary outcome is the reduction of skin thickness evaluated by the modified Rodnan skin score. In patients with SSc the skin

score assesses the skin fibrosis and correlates with both systemic involvement and progression of the disease

Secondary Objective: As for other values, the proposed action has the following objectives:

- to improve communication between different Italian groups presently engaged in the research of pathogenesis and the ensuing

possibilities for the specific therapy of chronic fibrotic disorders;

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- to increase the collaboration in joint projects;

- to avoid costly overlap;

- to facilitate the contact between basic research and clinical studies as well as exchange of ideas, material and technology;

- to allow comparison and pooling of data;

- to study the safety and efficacy of a novel therapeutic approach in a subgroup of patients with a rare disease requiring

collaboration of several research groups.

Main Objective: Specific objective of the present study is to treat scleroderma skin fibrosis using a therapeutic strategy based on pathogenetic

mechanisms (N-Acetylcisteine). It is anticipated that the impact of the expected findings to health care may be considerable since they may be applied

to more common organ-based fibrosis for which scleroderma remains a well known paradigm.

Secondary ID(s)

NAC2006