The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
This trial is active, not recruiting.
|Treatments||saline, dg3173, octreotide|
|Sponsor||Aspireo Pharmaceuticals Limited|
|Start date||January 2014|
|End date||September 2015|
|Trial size||20 participants|
|Trial identifier||NCT02217800, DG3173-II-02|
This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
The number of patients who achieve a trough hGH concentration of <2.5µg/L during the last 12 hours of the 23 hour profile following each study treatment.
time frame: 23 hours following each treatment
Male or female participants at least 18 years old.
Inclusion Criteria: - Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception - Diagnosis of acromegaly of pituitary origin - Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening - Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening - Have given written informed consent - Ability to comply with the requirements of the protocol for the study Exclusion Criteria: - Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant - Treatment with dopamine agonists in the 3 months prior to screening - Uncontrolled hypertension - Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin [HbA1c] ≥7.5%) and patients requiring insulin treatment - Gallstones or gravel that could cause biliary obstruction - Hyperprolactinaemia - Participation in a clinical study within 60 days prior to screening - Receipt of blood, blood products or plasma derivatives 60 days prior to screening - Body mass index (BMI) below 22 or above 37 kg/m2 - Pregnancy, lactation or use of any hormonal based contraceptives - Concomitant intake of corticosteroids or levodopa - A history of active alcohol abuse or drug addiction - Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2 - Evidence or suspicion of tumour expansion - Clinically significant abnormality in screening ECG in the opinion of the Investigator - Any clinically significant abnormal in screening laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator - Any disease which in the Investigator's opinion would exclude the patient from the study
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