A trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® in previously human growth hormone treated adults with growth hormone deficiency
- Conditions
- Growth hormone deficiency in adultsMedDRA version: 18.1Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2014-000290-39-DK
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Safety<br>- Occurrence of anti-NNC0195-0092 antibodies<br>Efficacy<br>- 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)