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
Status: | Recruiting |
---|---|
Conditions: | Endocrine, Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 1 - 18 |
Updated: | 1/12/2019 |
Start Date: | December 19, 2017 |
End Date: | December 2021 |
Contact: | Michael Beckert, MD |
Email: | mb@ascendispharma.com |
Phone: | +49 172-155-2596 |
enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial
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. Approximately 300 children (males and females) with GHD will be included.
All study participants will receive TransCon hGH. This is a global trial that will be
conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia,
Russia and Australia.
children with growth hormone deficiency (GHD) who previously participated in a phase 3
TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included.
All study participants will receive TransCon hGH. This is a global trial that will be
conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia,
Russia and Australia.
Inclusion Criteria:
1. Children who have completed a prior phase 3 TransCon hGH trial
2. Children who have not permanently discontinued study drug in the prior trial
3. 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 Criteria:
1. Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications
2. Evidence of closed epiphyses, defined as bone age > 14.0 years for females or > 16.0
years for males
3. Major medical conditions unless approved by Medical Expert
4. Known hypersensitivity to the components of the trial medication
5. Likely to be non-compliant with respect to trial conduct (in regards to the subject
and/or the parent/legal guardian/caregiver)
6. Pregnancy
7. Any other reason that in the opinion of the investigator would prevent the subject
from completing participation or following the trial schedule
We found this trial at
22
sites
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