Status:
COMPLETED
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
Lead Sponsor:
Ascendis Pharma A/S
Conditions:
Growth Hormone Deficiency, Pediatric
Endocrine System Diseases
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial....
Eligibility Criteria
Inclusion
- Children who have completed a prior phase 3 TransCon hGH trial
- Children who have not permanently discontinued study drug in the prior trial
- Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC
Exclusion
- Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications
- Evidence of closed epiphyses, defined as bone age \> 14.0 years for females or \> 16.0 years for males
- Major medical conditions unless approved by Medical Expert
- Known hypersensitivity to the components of the trial medication
- Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
- Pregnancy
- Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT03344458
Start Date
December 19 2017
End Date
February 21 2023
Last Update
May 8 2024
Active Locations (42)
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1
Ascendis Pharma Investigational Site
Birmingham, Alabama, United States, 35233
2
Ascendis Pharma Investigational Site
Los Angeles, California, United States, 90048
3
Ascendis Pharma Investigational Site
Orange, California, United States, 92868
4
Ascendis Pharma Investigational Site
Sacramento, California, United States, 95821