WUH: A 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 trial.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Growth Hormone Deficiency
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Age: Between 3 years - 12 years
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Gender: Male or Female
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Other 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 institutional review board/human research ethics committee/independent ethics committee (IRB/HREC/IEC)
You may not be eligible for this study if the following are true:
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- 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 (inregards 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
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.