Pulmonary arterial hypertension associated with systemic sclerosis
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: C225
Pharmaceutical Form: Intravenous infusion
Sponsors
VU University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for inclusion in this study only if all of the following criteria apply: 1. Written informed consent 2. Systemic sclerosis 3. PAH with a mean PAP of above 25 mmHg measured during rest. 4. PVR above 300 dynes 5. TLC > 70 % 6. NYHA class III or^6MWT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject is excluded from this study only if one or more of the following criteria apply: 1. Left ventricular dysfunction 2. Valvular heart disease 3. Pericardial constriction 4 Wedge pressure ³ 15 mmHg 4. Chronic thromboembolic pulmonary hypertension 5. Uncontrolled sleep apnea. 6. History of malignancies 7. Overt right heart failure 8. Medication changes 1 month prior to start study 9. Women of child-bearing potential (WOCB) who are unwilling or unable to use contraceptives 10. Sexually active fertile man not using effective birth control if their partners are WOCB 11. Severe abnormality of the cornea 12. Inadequate hematologic function defined by an absolute neutrophil count 1,5 times ULN (alternative: Cockroft <50 ml/min). 15. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole (see section 6.4.5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of EGFR inhibition therapy with Cetuximab in patients with pulmonary arterial hypertension associated with systemic sclerosis;Secondary Objective: Assess efficacy of EGFR inhibition therapy with Cetuximab in patients with pulmonary arterial hypertension associated with systemic sclerosis;Primary end point(s): Safety Efficacy | — |
Countries
Netherlands
Outcome results
None listed