Status:
COMPLETED
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels
- The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN when treated with somatostatin analogue, on a daily basis for at least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the last injection
- At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir \> 1 µg/L (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the 3rd injection of lanreotide Autogel 120 mg
Exclusion
- The patient has undergone pituitary surgery or radiotherapy within 6 months prior to study entry, or it is anticipated that it will be done during the study
- The patient has already been treated with a somatostatin analogue associated with a GH antagonist
- The patient has received dopamine agonist within 6 weeks prior to the study entry
- The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT, alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)
- The patient is at risk of pregnancy or is lactating
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00383708
Start Date
October 1 2006
End Date
October 1 2008
Last Update
September 27 2022
Active Locations (24)
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1
University Hospital, Charles University
Hradec Králové, Czechia, 500 05
2
Charles University
Prague, Czechia, 120 00 PRAHA 2
3
Aarhus Kommunehospital
Aarhus, Denmark
4
Groupe Hospitalier Henri Mondor- Albert Chenevier
Créteil, France