Acromegaly Clinical Trial
— DOPAACRO 002Official 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
Verified date | March 2019 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.
Status | Terminated |
Enrollment | 4 |
Est. completion date | June 2, 2017 |
Est. primary completion date | May 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU de Liège, University of Liège, Domaine Universitaire du Sart-Tilman | Liège | |
Hungary | Medical Centre, University of Pecs, I Department of Internal Medicine | Pecs | |
Serbia | Clinical Center of Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases | Belgrade | |
Ukraine | "Institute of Endocrinological Pathology named after Danilevskij V.Ya., AMS of Ukraine", Department of General Endocrinology | Kharkiv | |
Ukraine | "Institute of Endocrinology and Metabolism named after V.P.Komisarenko, AMS Ukraine", Department of General Endocrinology | Kiev | |
Ukraine | Vinnitsa Regional Endocrinology Dispensary, Vinnitsa National Medical University named after M.I Pirogov, Therapeutic Department ? 2 | Vinnitsa |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Belgium, Hungary, Serbia, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period | 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. | From baseline (Day -1) to Day 14. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06344650 -
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
|
||
Active, not recruiting |
NCT02092129 -
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.
|
N/A | |
Completed |
NCT02012127 -
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
|
||
Active, not recruiting |
NCT01265121 -
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
|
N/A | |
Terminated |
NCT00765323 -
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
|
Phase 3 | |
Completed |
NCT00500227 -
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
|
||
Completed |
NCT00531908 -
Physiopathology of Sodium Retention in Acromegaly
|
N/A | |
Completed |
NCT01278342 -
Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
|
Phase 4 | |
Active, not recruiting |
NCT01809808 -
A Prospective Study of Outcome After Therapy for Acromegaly
|
||
Completed |
NCT00145405 -
Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
|
Phase 4 | |
Completed |
NCT00210457 -
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
|
Phase 3 | |
Recruiting |
NCT05401084 -
Diet in the Management of Acromegaly
|
N/A | |
Recruiting |
NCT00005100 -
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
|
N/A | |
Completed |
NCT00521300 -
Preoperative Octreotide Treatment of Acromegaly
|
Phase 4 | |
Completed |
NCT03548415 -
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
|
Phase 2 | |
Not yet recruiting |
NCT04066569 -
Reproducibility and Utility of OGTT in Acromegaly
|
N/A | |
Not yet recruiting |
NCT05298891 -
Hypoproteic Diet in Acromegaly
|
N/A | |
Recruiting |
NCT04520646 -
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
|
N/A | |
Not yet recruiting |
NCT04529356 -
The TMS Treatment for Postoperative Headache in GH Tumor
|
N/A | |
Active, not recruiting |
NCT03252353 -
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
|
Phase 3 |