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

INTERVENTION: Trade Name: Somavert Product Name: pegvisomant Product Code: PN‐800467 Pharmaceutical Form: Powder and solvent for cutaneous solution INN or Proposed INN: PEGVISOMANT CAS Number: 218620‐50‐9 Pharmaceutical form of the placebo: Powder and solution for solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: acromegaly Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: 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 Primary end point(s): Change in the Quality of Life over 16 weeks. Assessed by AcroQoL and PASQ. Secondary Objective: To assess the effect of low‐dose pegvisomant co‐administration on: ; ? Total body water / body weight.; ? Blood pressure; ? HbA1c; ? BNP levels; ? Ring‐size; ? IGF‐I levels; ? Safety based on:; • Adverse events, clinical examination, vital signs; • Glucose tolerance; • Standard hematology and biochemistry, including liver function tests; Timepoint(s) of evaluation of this end point: At 16 weeks, end of study SECONDARY OUTCOME: Secondary end point(s): Secondary Efficacy Variables:; ? Total body water /body weight.; ? Blood pressure; ? HbA1c; ? BNP levels; ? Ring‐size; ? IGF‐I levels; ? GH levels; ? PEG‐levels; ? cardiac‐sonography; 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.; 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. INCLUSION CRITERIA: 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. INCLUSION CRITERIA: 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 ag