Het effect van pegvisomant op kwaliteit van leven en insuline gevoeligheid.The effect of pegvisomant on quality of life and insulin sensitivity
- Conditions
- GH IGF1, pituitary tumor, AcromegalyGroeihormoon IGF1 hypofyse tumor Acromegalie
- Registration Number
- NL-OMON24622
- Lead Sponsor
- Dept. of Medicine, Erasmus University MCDepartment of Endocrinology and Metabolism, Leiden University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Variables: <br /><br>Change in the Quality of Life over 16 weeks. Assessed by AcroQoL and PASQ.
- Secondary Outcome Measures
Name Time Method Safety Variables:<br /><br>Adverse event and local tolerance information recorded at any time throughout the study.<br /><br>Vital signs recorded at visits V1, V2, V3, V4, V5 & V6. <br /><br>Physical examination recorded at visits V1, V2, V4 & V6.<br /><br>Cardiac- sonography and glucose tolerance based on oral glucose tolerance test measured at visits V1 and V6. HbA1C will be measure at visits V1, V2, V3, V4, V5 & V6.<br>Laboratory tests: QoL, standard hematology and biochemistry plus, IGF-I levels, GH levels, PEG-levels, ALT, AST, GGT, AP, PT and total bilirubin will be measured at visits V1, V2, V4, V5 and V6.<br /><br>Pituitary MRI prior and at the end of the study.<br /><br>Pharmacokinetic Variables:<br /><br>Pegvisomant serum levels will be assessed in all patients at visits V2, V4, V6.