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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR858 |
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Date of registration:
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29/12/2006 |
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Primary sponsor: |
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Public title:
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The Effects of Epidermal Growth Factor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis.
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Scientific title:
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The Effects of Epidermal Growth Factor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis. A phase II open-label safety and efficacy study. - N/A |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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20 |
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Recruitment status: |
other |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=858 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.
Boonstra |
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Address:
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VU University Medical Center, Department of Pulmonary Diseases,
P.O. Box 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4444782 |
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Email:
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a.boonstra@vumc.nl |
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Affiliation:
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Name:
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A.
Boonstra |
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Address:
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VU University Medical Center, Department of Pulmonary Diseases,
P.O. Box 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4444782 |
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Email:
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a.boonstra@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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 and/or 6 Minute Walk Test < 80% predicted;
7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment;
8. Stability on medication during the previous 3 months (defined as stable or decrease of 6 MWT after 3 months of treatment).
Exclusion criteria: A subject will be excluded from this study in case of the following criteria:
1. Left ventricular dysfunction;
2. Valvular heart disease;
3. Pericardial constriction;
4. Wedge pressure >/= 15 mmHg;
5. Chronic thromboembolic pulmonary hypertension;
6. Uncontrolled sleep apnea;
7. History of malignancies;
8. Overt right heart failure;
9. History or presence of skin ulcerations;
10. Women of child-bearing potential (WOCB) who are unwilling or unable to use contraceptives;
11. Sexually active fertile man not using effective birth control if their partners are WOCB;
12. Severe abnormality of the cornea;
13. Inadequate hematologic function defined by an absolute neutrophil count < 1,500/mm3, platelet count < 80.000/mm3 and hemoblobin level of < 9 g/dL;
14. Inadequate hepatic function defined by a total bilirubin level 1.5 times the upper limit of normal (ULN) and ASAT levels 2.5 times ULN;
15. Inadequate renal function defined by a serum creatinine level > 1,5 times ULN (alternative: Cockroft <50 ml/min);
16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole (see section 6.4.5).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Sclerosis-associated pulmonary arterial hypertension (SScPAH)
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Intervention(s)
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All participants will receive cetuximab at a loading dose of 400 mg/m2 in week 1, followed by a weekly dose of 250 mg/m2 starting from week 2, up to a total of 12 weeks.
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Primary Outcome(s)
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Safety.
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Secondary Outcome(s)
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Efficacy, measured by effects on six minute walk test, stroke volume, changes n HRCT, NT-pro-BNP.
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Secondary ID(s)
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155/2006
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ISRCTN75611179
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Source(s) of Monetary Support
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VU University Medical Center
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