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PHASE III, MULTICENTRE, OPEN STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILES OF THE CO-ADMINISTRATION OF LANREOTIDE AUTOGEL 120 MG (ADMINISTERED VIA DEEP SUBCUTANEOUS INJECTIONS EVERY 28 DAYS) AND PE...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-000297-72

PHASE III, MULTICENTRE, OPEN STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILES OF THE CO-ADMINISTRATION OF LANREOTIDE AUTOGEL 120 MG (ADMINISTERED VIA DEEP SUBCUTANEOUS INJECTIONS EVERY 28 DAYS) AND PEGVISOMANT 40 TO 120 MG PER WEEK (ADMINISTERED VIA SUBCUTANEOUS ROUTE ONCE OR TWICE A WEEK) IN ACROMEGALIC PATIENTS FAILING TO RESPOND TO LANREOTIDE AUTOGEL 120 MG ALONE

Femme et Homme

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Extrait

To assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via subcutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Critère d'inclusion

  • Acromegalic patients that will enter the co-treatment period should either be treated: with daily injections of pegvisomant for at least 3 months. Patients should either have a normal IGF-1 level or receive pegvisomant 30 mg daily administration. Or with lanreotide Autogel or octreotide LAR, for at least 6 months. Patients should have received the highest marketed dose during the last 3 months and should have a serum IGF-1 level above the upper limit of normal (ULN) under such treatment

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