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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ascendis Pharma A/S
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
