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

Phase 2

Terminated

• Conditions: Acromegaly
• Interventions: Drug: BIM 23A760

• Registration Number: NCT00994214
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2015-10-14
• Results First Submitted QC: 2016-01-07
• Results First Posted: 2016-02-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIM 23A760 6 mg	BIM 23A760	-
BIM 23A760 2 mg	BIM 23A760	-
BIM 23A760 1 mg	BIM 23A760	-
BIM 23A760 4 mg	BIM 23A760	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1	At Month 6

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1	At Month 1
Number of Subjects Reported Adverse Events During the Study	Up to Visit 10 (An average of 6.5 Months)	For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen.; TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.
Percentage Change in Ring Finger Circumference	Baseline (Day 1) and Month 6	Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6	0-3 hr on Baseline (Day 1) and Months 1, 3 and 6	Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
Changes in IGF-1	Baseline (Day 1) and Month 6

Trial Locations

Locations (23)

Pituitary Center; 🇺🇸 Los Angeles, California, United States

Massachusetts General Hospital / Neuroendocrine Unit; 🇺🇸 Boston, Massachusetts, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

Hospital Universitário Clementino Fraga Filho; 🇧🇷 Rio de Janeiro, Brazil

Hospital das Clínicas de São Paulo; 🇧🇷 Sao Paulo, Brazil

General University Hospital, Clinic of Internal Medicine,; 🇨🇿 Praha, Czechia

University Hospital Olomouc, Clinic of Internal Medicine; 🇨🇿 Olomouc, Czechia

Hôpital de la Timone; 🇫🇷 Marseille, France

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 City, Mexico

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

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Department of Endocrinology, Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Oregon University, Dept. of Endocrinology and Neurosurgery; 🇺🇸 Portland, Oregon, United States

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

P. Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia