NCT00383708

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	lanreotide (Autogel formulation)	120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
DRUG	Pegvisomant	Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-10-03
• Last updated: 2022-09-27
• Results posted: 2018-07-23

Locations

24 sites across 10 countries: Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom