Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

Stopped early · Phase 2

Conditions studied: Acromegaly

In brief

The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Key facts

Study ID

NCT00994214

Run by

Ipsen

People needed

109

Starts

2009-10-01

Expected to finish

2011-02-01

Last updated by the study team

2019-11-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• IGF-1 ≥1.3 x upper limit normal (ULN)
• Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
• Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

You may not qualify if…

• The patient has received long acting somatostatin analogues within 6 months of study entry
• The patient has undergone radiotherapy at any time prior to study entry
• The time between pituitary surgery (if any) and study entry is less than 6 weeks
• The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Where it is running

• Pituitary Center — Los Angeles, California, United States
• Massachusetts General Hospital / Neuroendocrine Unit — Boston, Massachusetts, United States
• Oregon University, Dept. of Endocrinology and Neurosurgery — Portland, Oregon, United States
• UZ Leuven — Leuven, Belgium
• Centre Hospitalier Universitaire de Liège — Liège, Belgium
• Hospital Universitário Clementino Fraga Filho — Rio de Janeiro, Brazil
• Hospital das Clínicas de São Paulo — São Paulo, Brazil
• University Hospital Olomouc, Clinic of Internal Medicine — Olomouc, Czechia
• General University Hospital, Clinic of Internal Medicine, — Prague, Czechia
• Hôpital Bicêtre — Le Kremlin-Bicêtre, France
• Hôpital de la Timone — Marseille, France
• P. Stradins Clinical University Hospital — Riga, Latvia
• Kaunas Medical University Hospital — Kaunas, Lithuania
• Vilnius University Hospital "Santariskiu Klinikos" — Vilnius, Lithuania
• UIM Endocrinología Experimental, Hospital de Especialidades — Mexico City, Mexico
• Insituto Nacional de Neurologia y Neurocirugia — México, Mexico
• Department of Endocrinology, Erasmus MC — Rotterdam, Netherlands
• Voivodeship Specialistic Hospital No 3 — Rybnik, Poland
• "C.I. Parhon" National Institute of Endocrinology — Bucharest, Romania
• Karolinska University Hospital — Stockholm, Sweden
• Academy of Medical Science of Ukraine, Department of Clinical Endocrinology — Kharkiv, Ukraine
• Administration of Medical Services and Rehabilitation of "ARTEM" — Kyiv, Ukraine
• National Medical University n.a. M.I.Pirogov — Vinnitsa, Ukraine

Full record on ClinicalTrials.gov

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