Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF-I levels has been normalized by long-acting somatostatin analogues

Dept. of Medicine, Erasmus University MCDepartment of Endocrinology and Metabolism, Leiden University Medical Center0 sites40 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: GH IGF1, pituitary tumor, AcromegalyGroeihormoon IGF1 hypofyse tumor Acromegalie
Sponsor: Dept. of Medicine, Erasmus University MCDepartment of Endocrinology and Metabolism, Leiden University Medical Center
Enrollment: 40
Status: Not yet recruiting
Last Updated: 2 years ago

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Dept. of Medicine, Erasmus University MCDepartment of Endocrinology and Metabolism, Leiden University Medical Center

•A written informed consent.
•Male or female age ≥ 18 years. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF1 levels.
•The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF1 level above the 60th percentile and below 1\.2 x ULN, 28 days after the last injection.

•Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
•If patients have an optimal QoL (100%) assessed by the AcroQoL physical dimension, they cannot enter the study.
•It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
•Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure.
•Has already been treated with a somatostatin analogue associated with pegvisomant.
•Has received a dopamine agonist within 6 weeks prior to study entry.
•Has been treated with any unlicensed drug within the last 30 days before study entry.
•Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN).
•Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non\-childbearing potential is defined as post\-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study.
•Has a history of, or known current, problems with alcohol or drug abuse.