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

Acromegaly Clinical Trial

— TULIPIA  

Official title:

Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00994214
• Other study ID #: 2-55-52060-003
• Secondary ID: 2009-010787-42
• Status: Terminated
• Phase: Phase 2
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• BIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Czechia,  France,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Romania,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Mean GH =2.5 ng/mL and Normalised IGF-1		At Month 6
Secondary	Percentage of Subjects With Mean GH =2.5 ng/mL and Normalised IGF-1		At Month 3
Secondary	Percentage of Subjects With Mean GH =2.5 ng/mL and Normalised IGF-1		At Month 1
Secondary	Percent Change From Baseline in the Mean GH From 0-3 Hours at 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	0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Secondary	Changes in IGF-1		Baseline (Day 1) and Month 6
Secondary	Percentage Change in Ring Finger Circumference	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.	Baseline (Day 1) and Month 6
Secondary	Number of Subjects Reported Adverse Events During the Study	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.	Up to Visit 10 (An average of 6.5 Months)