A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children

September 18, 2018

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 (enliGHten)

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Parrimon, Yazandra; Anthony, Susan; Beltran, Yajira

  • IRB No: 18.029.02

    Protocol Abbrev: enliGHten

    Principal Investigator: Joshua H Yang, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: enliGHten

    Treatment: Once weekly subcutaneous injection of TransCon hGH

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03344458

  • Objective

    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 400 children (males and females) with GHD will be included. All study participants will receive TransCon hGH.

  • Key Eligibility

    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)
    7.Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule