At a glance
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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 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
In Brief
A Phase 3 clinical trial evaluating lanreotide (Autogel formulation) and Pegvisomant for Acromegaly. Completed, enrolled 125 participants across 24 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.