Conditions: Acromegaly
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 125
Healthy volunteers: no

Brief summary:
The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: lanreotide (Autogel formulation) intervention 2: Pegvisomant
Intervention descriptions: intervention 1: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks. intervention 2: Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Protocol document: