Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF1 levels has been normalized by long-acting somatostatin analogues - PEQo

Erasmus University Medical Centre Rotterdam0 sitesOctober 19, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 19, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Erasmus University Medical Centre Rotterdam

•Acromegalic patients will be recruited in order to ensure 40 evaluable patients will enter the co\-treatment period. All subjects should previously be treated with somatostatin analogues during which treatments their IGF\-I levels should have normalized.
•All patients must fulfill the following:
•At the screening visit,
•Provision of written informed consent prior to any study related procedures.
•Male or female aged between 18 and 75 years inclusive
•The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF\-1 levels.
•The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF\-1 level above the 60th percentile and below ULN, 28 days after the last injection.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Patients will not be included in the study if he/she:
•Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
•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.