Acromegaly somatotrofinomas
Conditions
Interventions
Treatment with Pegvisomant 40 mg weekly or placebo
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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. Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. * Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject*s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. * Renal insufficiency, clearance < 60 ml/min * Participation in a clinical trail in the last 12 months
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Study Objectives: To assess the effect of low-dose pegvisomant co-administration on: * Total body water / body weight. * Blood pressure * HbA1c * BNP levels * Ring-size * IGF-I levels * Safety based on: * Adverse events, clinical examination, vital signs * Glucose tolerance * Standard hematology and biochemistry, including liver function tests | — |
Primary
| Measure | Time frame |
|---|---|
| change in the AcroQol-physical score at the end of the treatment period | — |
Countries
Netherlands
Outcome results
None listed