A study on the efficacy and safety of long-acting pasireotide with or without pegvisomant in patients with controlled acromegaly previously treated with long acting somatostatin analogs en weekly pegvisomant.

• Conditions: Acromegaly; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-002219-41-NL
• Lead Sponsor: Erasmus Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

A written informed consent.
Male or female age = 18 years.
The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels.
The patient is treated with lanreotide Autosolution or octreotide LAR for at least 6 months and has a serum IGF-I level above the 60th percentile and below 1.2 x 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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 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 3 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 < 50 ml/min.
Poorly controlled Diabetes Mellitus with an HbA1c > 9.0%.
Patients with a QTc > 500 ms on the EKG.
Participation in a clinical trial in the last 6 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified