Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly (DOPAACRO 002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045302
Recruitment Status : Terminated (Early termination is a sponsor decision. No new safety signal or serious adverse event has been observed.)
First Posted : February 7, 2017
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: BIM23B065 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa, Open-label, Single-arm, Two Stage, Multi-centre Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Repeated Subcutaneous Administration of BIM23B065 in Subjects With Acromegaly
Actual Study Start Date : January 26, 2017
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIM23B065 Drug: BIM23B065
Subcutaneous twice a day or three times a day administration of BIM23B065. Dose will be 0.4, 0.6, 0.8 or 1 mg (twice a day or three times a day).




Primary Outcome Measures :
  1. The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period [ Time Frame: From baseline (Day -1) to Day 14. ]
    A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or >50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provided written informed consent prior to any study related procedures.
  • Subjects will have a documented diagnosis of acromegaly.
  • Subjects will have active acromegaly confirmed by a mean serum concentration of GH over 2 hours > 2.5 µg/L at screening analysed by central laboratory.
  • Subjects who have had pituitary surgery must be >8 weeks post-surgery.
  • 18 to 75 years of age.
  • Negative pregnancy test (female subjects).
  • Female who is either of non-childbearing potential or who is not pregnant at screening and agrees to use highly effective contraception during whole duration of the study. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
  • Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use a medically accepted, effective method of contraception (i.e. condom) for the duration of the treatment period of the study.

Exclusion Criteria:

  • The subject has received long-acting Somatostatin Analogues (SSA) within 12 weeks prior screening (e.g.octreotide long acting release (LAR), lanreotide Autogel, pasireotide LAR).
  • The subject has received short-acting SSA within 1 week (e.g. octreotide SC) prior to screening.
  • The subject has received a dopamine agonist within 6 weeks (e.g., bromocriptine or cabergoline) prior to screening.
  • The subject has received GH antagonist within 12 weeks prior to screening (e.g., pegvisomant).
  • The subject had undergone radiotherapy to the pituitary gland at any time prior to study entry.
  • It is anticipated that the subject will undergo pituitary surgery or radiation to the pituitary gland during the study, or will require additional medical therapy for acromegaly (including SSA, pegvisomant, or dopamine agonists) during the study.
  • The subject has unsubstituted/untreated adrenal insufficiency.
  • If the subject has any history of postural hypotension or evidence of postural hypotension at screening (>= 20 mm Hg decrease in Systolic blood pressure (SBP), >= 10 mm Hg decrease in diastolic blood pressure, or >=30 bpm increases in pulse rate, after standing for 2 minutes from resting supine position of at least 10 min).
  • Subject with poorly controlled diabetes mellitus (presence of ketoacidosis or a glycosylated hemoglobin level >10%).
  • Subject with diabetes treated with insulin for less than 6 weeks prior to study entry, or with an unstable insulin dose in the 6 weeks prior to study entry or HbA1c>10%.
  • Subject is taking beta-blockers (which can inhibit compensatory increases in HR during hypotensive episodes).
  • Subject is being treated for hypertension and in the opinion of the investigator their antihypertensive medication puts them at increased risk of postural hypotension.
  • Subject is hypotensive at screening as defined as systolic < 90 mmHg and/or diastolic <60 mmHg.
  • Subject has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 x ULN and/or alkaline phosphatase (AP) ≥2 x ULN and/or total bilirubin ≥1.5 x ULN and gamma-glutamyl transferase (GGT) ≥2.5 x ULN during the Screening period (local laboratory results).
  • Subject has a compression of the optic chiasm causing visual-field defects.
  • Subject is receiving any oestrogen-containing Hormone Replacement Therapy (HRT).
  • Subject has clinically significant pancreatic abnormalities and/or amylase and/or lipase ≥2 x ULN during the Screening period (local laboratory results).
  • Any significant renal abnormalities, including confirmed proteinuria and/or creatinine ≥1.5x ULN during screening assessed by the local laboratory.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045302


Locations
Layout table for location information
Belgium
CHU de Liège, University of Liège, Domaine Universitaire du Sart-Tilman
Liège, Belgium, B-4000
Hungary
Medical Centre, University of Pecs, I Department of Internal Medicine
Pecs, Hungary, 7624
Serbia
Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, Serbia, 11000
Ukraine
"Institute of Endocrinological Pathology named after Danilevskij V.Ya., AMS of Ukraine", Department of General Endocrinology
Kharkiv, Ukraine, 61002
"Institute of Endocrinology and Metabolism named after V.P.Komisarenko, AMS Ukraine", Department of General Endocrinology
Kiev, Ukraine, 04114
Vinnitsa Regional Endocrinology Dispensary, Vinnitsa National Medical University named after M.I Pirogov, Therapeutic Department № 2
Vinnitsa, Ukraine, 21010
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Study Director Ipsen
  Study Documents (Full-Text)

Documents provided by Ipsen:
Study Protocol  [PDF] September 14, 2016
Statistical Analysis Plan  [PDF] February 10, 2017


Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03045302    
Other Study ID Numbers: D-FR-10380-002
2015-003868-37 ( EudraCT Number )
First Posted: February 7, 2017    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases