Status:
COMPLETED
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
Lead Sponsor:
Ascendis Pharma Endocrinology Division A/S
Conditions:
Growth Hormone Deficiency, Pediatric
Endocrine System Diseases
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included. A...
Eligibility Criteria
Inclusion
- Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy.
- 6 months to 17 years old, inclusive, at Visit 1
- If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1
- If ≥ 6 months but \< 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1
- Tanner stage \< 5 at Visit 1
- Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males)
- 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
- Weight of \< 5.5 kg or \> 80 kg at Visit 1
- Females of child-bearing potential
- History of malignant disease
- Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism)
- Poorly-controlled diabetes mellitus (HbA1c \>8.0%) or diabetic complications
- Known neutralizing antibodies against hGH
- Major medical conditions, unless approved by Medical Monitor
- Pregnancy
- Presence of contraindications to hGH treatment
- Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
- Participation in any other trial of an investigational agent within 30 days prior to Visit 1
- Prior exposure to investigational hGH
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2019
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03305016
Start Date
November 13 2017
End Date
March 19 2019
Last Update
January 4 2022
Active Locations (24)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Neufeld Medical Group Inc.
Los Angeles, California, United States, 90048
3
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
4
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado, United States, 80112