Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
NCT ID: NCT00994214
Last Updated: 2019-11-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
109 participants
INTERVENTIONAL
2009-10-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIM 23A760 1 mg
BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
BIM 23A760 2 mg
BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
BIM 23A760 4 mg
BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
BIM 23A760 6 mg
BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Interventions
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BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
Countries
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Other Identifiers
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2009-010787-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2-55-52060-003
Identifier Type: -
Identifier Source: org_study_id
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