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
- Conditions
- Acromegalysomatotrofinomas10021112
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>change in the AcroQol-physical score at the end of the treatment period</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Study Objectives:<br /><br>To assess the effect of low-dose pegvisomant co-administration on:<br /><br>* Total body water / body weight.<br /><br>* Blood pressure<br /><br>* HbA1c<br /><br>* BNP levels<br /><br>* Ring-size<br /><br>* IGF-I levels<br /><br>* Safety based on:<br /><br>* Adverse events, clinical examination, vital signs<br /><br>* Glucose tolerance<br /><br>* Standard hematology and biochemistry, including liver function tests</p><br>