Somavert (Pegvisomant) is approved for the treatment of acromegalic patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy as Somatostatin Analoga. The effects of Pegvisomant on the cardiac function in patients with active acromegaly followed by left ventricular hypertrophy or cardiac insufficiency will be investigated. MedDRA version: 7.0 Level: llt Classification code 10061835
Conditions
Interventions
Trade Name: Somavert 10 mg
Product Name: Pegvisomant
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Pegvisomant
Other descriptive name: Growth Hormone Recept
Sponsors
Clinic of University of Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Active acromegaly in adult subjects (= 18 years) after surgery and/or radiation therapy with elevated IGF-1 levels despite treatment with somatostatin analogues or dopamine agonists 2) Pegvisomant therapy is indicated (i. e. patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy, or for whom these therapies are not appropriate) 3) Evidence of left ventricular hypertrophy (infero-lateral wall thickness = 12 mm assessed by echocardiography) or 4) Evidence of impaired diastolic function (= stage 2 as assessed by echocardiography) or 5) Evidence of systolic dysfunction (Ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy and lactation period 2) Previous therapy with Pegvisomant 3) Suspected or known hypersensitivity to the drug or any of its components 4) Contraindications for MRI 5) History of malignancy during the last 5 years 6) Suspected or known drug or alcohol abuse 7) Patients who are neither able to self administer study medication on a daily basis nor have a caregiver who can administer study medication to the patient on a daily basis 8) Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion 9)Participation in another clinical trial 10) Pituitary adenoma with a distance to the optic chiasm of < 3 mm 11) Any other drug for treatment of acromegaly (e.g. dopamine agonists, Somatostatin analogues) which would be necessary during the study or patients who apply for radiotherapy 12) Instable heart insufficiency classified as NYHA IV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pegvisomant was shown to be more effective in the normalization of IGF-I levels than currently available drug therapy for acromegaly. In addition, Pegvisomant has Only a few reported side effects. This study will investigate the efficacy and safety of Pegvisomant in patients who have persistent acromegaly following surgery and who are insufficiently pretreated or not appropriate for treament with somatostatin analogs, dopamine agonists, or radation therapy. The efficacy will be assessed by changes of IGF-I over 12 months. The aim of the study is to investigate the effects of Pegvisomant on the cardiac function in patients with active acromegaly and left ventricular hypertrophy or cardiac insufficiency who were normalized in IGF-I level. ;Secondary Objective: Further changes in insulin metabolism and influence of Pegvisomant on endothelial progenitor cells (as a marker for atherosclerotic plaques formation) should be investigated.;Primary end point(s): The primary endpoint is the change in peak systolic strain rate (SRSYS) determined by Color Doppler Myocardial Imaging (CDMI). | — |
Countries
Germany
Outcome results
None listed