Growth hormone deficiency in adults MedDRA version: 17.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Code: NNC0195-0092 PDS290 10 mg/1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: N/A
CAS Number: 1338578-34-9
Other descriptive name: NNC0195-0092
Conc
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent 2. Adult growth hormone deficiency diagnosed = 6 months (defined as 180 days) prior to screening 3. Treatment with hGH for at least 6 months at screening 4. If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision - Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject’s file 2. For patients with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years: - Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as = 365 days) before randomisation. Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent MRI or CT scan must be performed = 9 months (defined as = 270 days) prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical safety of once weekly dosing of NNC0195-0092 during 26 weeks of treatment in AGHD subjects previously treated with daily hGH;Secondary Objective: To evaluate the degree of treatment satisfaction of once weekly dosing of NNC0195-0092 during 26 weeks of treatment in AGHD subjects previously treated with daily hGH;Primary end point(s): Incidence of adverse events, including injection site reactions ;Timepoint(s) of evaluation of this end point: From baseline to the end of the treatment period (26 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety - Occurrence of anti-NNC0195-0092 antibodies Efficacy - Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scores (effectiveness, convenience, and global satisfaction scores);Timepoint(s) of evaluation of this end point: From baseline (randomisation) to end of treatment period (26 weeks) | — |
Countries
Denmark, European Union, Japan, Sweden, United Kingdom
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed