the effect of the addition of pegvisomant on quality of life and glucose sensitivity in acromegaly patients
- Conditions
- acromegalyTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2011-004231-31-NL
- Lead Sponsor
- Erasmus University Medical Centre Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the Quality of Life over 16 weeks in 60 acromegalic patients;Secondary Objective: To assess the effect of low-dose pegvisomant co-administration on: <br>?Total body water / body weight.<br>?Blood pressure<br>?HbA1c<br>?BNP levels<br>?Ring-size<br>?IGF-I levels<br>?Safety based on:<br>•Adverse events, clinical examination, vital signs<br>•Glucose tolerance<br>•Standard hematology and biochemistry, including liver function tests<br>;Primary end point(s): Change in the Quality of Life over 16 weeks. Assessed by AcroQoL and PASQ.;Timepoint(s) of evaluation of this end point: At 16 weeks, end of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Variables:<br>?Total body water /body weight.<br>?Blood pressure<br>?HbA1c<br>?BNP levels<br>?Ring-size<br>?IGF-I levels<br>?GH levels<br>?PEG-levels<br>?cardiac-sonography<br>All parameters will be assessed at baseline (V1) plus at 4 (V2), 8 (V3), 12 (V4) and 16 weeks (V6; last visit) after start of co-treatment.<br>;Timepoint(s) of evaluation of this end point: All parameters will be assessed at baseline (V1) plus at 4 (V2), 8 (V3), 12 (V4) and 16 weeks (V6; last visit) after start of co-treatment.