Overview

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Status:
Completed
Trial end date:
2018-10-04
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Hormones
Criteria
Inclusion Criteria: - 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 - GHD diagnosed for at least 6 months
(defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive
months (defined as 180 days) at screening - 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 Exclusion Criteria: - Active malignant disease
or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ
carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
local excision 2/ 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 medical records - For subjects 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 below or equal to 365 days) before randomisation. Absence of
growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT
scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined
as below or equal to 270 days) prior to randomisation