This study will investigate the efficacy of once-weekly pegvisomant treatment in patients with acromegaly who have already achieved disease control on daily pegvisomant. The attraction of once weekly pegvisomant is obvious and would have implications for the development of a depot preparation.
Conditions
Interventions
Trade Name: Pegvisomant
Product Name: Somavert (pegvisomant)
Product Code: SOM022
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Christie Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with acromegaly, controlled by daily dose pegvisomant Stable daily dose for at least three months prior to enrolment Over 18 years of age Willing to provide informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unwilling to provide written consent Other conditions known to alter GH/IGF-I (severe hepatic disease, severe renal disease, malnutrition, ethanol and drug abuse) History of relevant food and drug allergies Pregnancy/lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the effect on once weekly pegvisomant therapy on some of the other associated biochemical/metabolic parameters which are abnormal in active acromegaly.;Main Objective: We propose to convert patients on a daily pegvisomant, initially, to the same total weekly amount but administered as two doses, rather than seven, per week, and subsequently as a once weekly dose. This is to enable us to look at the efficacy of a once weekly dosing regimen in controlling disease activity and patient quality of life in pegvisomant.;Primary end point(s): Weekly dose of pegvisomant required to normalize IGF-I | — |
Countries
United Kingdom
Outcome results
None listed