A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormo… (NCT03344458) | Clinical Trial Compass
CompletedPhase 3
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
United States298 participantsStarted 2017-12-19
Plain-language 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. 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.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]