Infusion at home ,using a pump device, of a drug that dilates peripheral blood vessels to treat patients affected by a disease named Systemic sclerosis, with manifestations caused by a reduced blood flow in hands and feet.

HOME INFUSION THERAPY WITH ILOPROST USING A PORTABLE SYRINGE PUMP FOR THE TREATMENT OF PERIPHERAL ULCERS AND RAYNAUD'S PHENOMENON IN SYSTEMIC SCLEROSIS. - iloporta

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004596-12-IT

Enrollment

Registered

2013-12-13

Start date

2014-01-22

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud's phenomenon and acral ulcers in systemic sclerosis

Interventions

Trade Name: Endoprost Product Name: Endoprost Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acral ulcers and / or Raynaud's phenomenon in patients affected by systemic sclerosis - A usable peripheral venous access or an avalaible central venous access. - Age above 18 years and below 80 years. - Informed consent signed by the patient - Women of childbearing potential who are willing to practice effective contraception for the infusion period 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Hypersensitivity to the active substance or to any of the excipients. - Pregnancy / Lactation. - Severe coronary heart disease or unstable angina. - Myocardial infarction within the previous six months. - Acute or chronic congestive heart failure (NYHA II - IV). - Serious arrhythmias.- Suspicion of pulmonary congestion. - Cerebrovascular events in the last 3 months. - Chronic renal failure (GFR <30 ml / min). - Cirrhosis . - Therapy with vasodilators - Active bleeding - Severe thrombocytopenia (PLT <20000/mmc). Severe anemia (Hb <8 g / dl). - Severe arterial hypertension not controlled. - Orthostatic hypotension.

Design outcomes

Primary

Measure	Time frame
Main Objective: feasibility of the home infusion therapy with endoprost;Secondary Objective: Safety and efficacy of the new method;Primary end point(s): 75% of patients completed the six-month treatment;Timepoint(s) of evaluation of this end point: 6° month	—

Secondary

Measure	Time frame
Secondary end point(s): Response of Raynaud's phenomenon and acral ulcers, patient satisfaction for the new method ;Timepoint(s) of evaluation of this end point: 1°,2°,3°,4°,5°,6° months	—

Countries

Italy

Contacts

Public ContactDay hospital Clinica Medica

SOD clinica Medica -OO. RR. Torrette di Ancona

Paolo.Fraticelli@ospedaliriuniti.marche.it00390715964203

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026