A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
NCT ID: NCT02781727
Last Updated: 2022-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2016-12-13
2019-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TransCon hGH
Once weekly subcutaneous injection of TransCon hGH
Once weekly subcutaneous injection of TransCon hGH
Once weekly subcutaneous injection
human growth hormone (Genotropin)
Once daily subcutaneous injection of Genotropin
Once daily subcutaneous injection of Genotropin
Once daily subcutaneous injection
Interventions
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Once weekly subcutaneous injection of TransCon hGH
Once weekly subcutaneous injection
Once daily subcutaneous injection of Genotropin
Once daily subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Boys: 3-12 years, inclusive
* Girls: 3-11 years, inclusive
* Impaired height (HT) defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS ≤ -2.0) according to the 2000 CDC Growth Charts for the United States Methods and Development, available at http://www.cdc.gov/growthcharts/
* Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay
* Bone age (BA) at least 6 months less than chronological age
* Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1)
* Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign)
Exclusion Criteria
* Prior exposure to recombinant hGH or IGF-1 therapy
* Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast) at Screening (MRI results from up to 6 months prior to Screening may be accepted)
* Children with psychosocial dwarfism
* Children with idiopathic short stature
* History or presence of malignant disease; any evidence of present tumor growth
* Closed epiphyses
* Major medical conditions and/or presence of contraindication to hGH treatment
* Participation in any other trial of an investigational agent within 3 months prior to Screening
3 Years
12 Years
ALL
No
Sponsors
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Ascendis Pharma Endocrinology Division A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Beckert, MD
Role: STUDY_DIRECTOR
Ascendis Pharma A/S
Aimee D Shu, MD
Role: STUDY_DIRECTOR
Ascendis Pharma, Inc.
Locations
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Ascendis Pharma Investigational Site
Birmingham, Alabama, United States
Ascendis Pharma Investigational Site
Little Rock, Arkansas, United States
Ascendis Pharma Investigational Site
Los Angeles, California, United States
Ascendis Pharma Investigational Site
Orange, California, United States
Ascendis Pharma Investigational Site
Centennial, Colorado, United States
Ascendis Pharma Investigational Site
Jacksonville, Florida, United States
Ascendis Pharma Investigational Site
Orlando, Florida, United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States
Ascendis Pharma Investigational Site
Jackson, Mississippi, United States
Ascendis Pharma Investigational Site
Lebanon, New Hampshire, United States
Ascendis Pharma Investigational Site
Mineola, New York, United States
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, United States
Ascendis Pharma Investigational Site
Portland, Oregon, United States
Ascendis Pharma Investigational Site
Dallas, Texas, United States
Ascendis Pharma Investigational Site
Fort Worth, Texas, United States
Ascendis Pharma Investigational Site
Tacoma, Washington, United States
Ascendis Pharma Investigational Site
Yerevan, , Armenia
Ascendis Pharma Investigational Site
Clayton, , Australia
Ascendis Pharma Investigational Site
Minsk, , Belarus
Ascendis Pharma Investigational Site
Varna, , Bulgaria
Ascendis Pharma Investigational Site
Tbilisi, , Georgia
Ascendis Pharma Investigational Site
Tbilisi, , Georgia
Ascendis Pharma Investigational Site
Tbilisi, , Georgia
Ascendis Pharma Investigational Site
Athens, , Greece
Ascendis Pharma Investigational Site
Milan, , Italy
Ascendis Pharma Investigational Site
Roma, , Italy
Ascendis Pharma Investigational Site
Grafton, , New Zealand
Ascendis Pharma Investigatonal Site
Gdansk, , Poland
Ascendis Pharma Investigational Site
Warsaw, , Poland
Ascendis Pharma Investigational Site
Iași, , Romania
Ascendis Pharma Investigational Site
Izhevsk, , Russia
Ascendis Pharma Investigational Site
Kazan', , Russia
Ascendis Pharma Investigational Site
Krasnoyarsk, , Russia
Ascendis Pharma Investigational Site
Moscow, , Russia
Ascendis Pharma Investigational Site
Moscow, , Russia
Ascendis Pharma Investigational Site
Nizhny Novgorod, , Russia
Ascendis Pharma Investigational Site
Novosibirsk, , Russia
Ascendis Pharma Investigational Site
Omsk, , Russia
Ascendis Pharma Investigational Site
Saint Petersburg, , Russia
Ascendis Pharma Investigational Site
Saint Petersburg, , Russia
Ascendis Pharma Investigational Site
Samara, , Russia
Ascendis Pharma Investigational Site
Saratov, , Russia
Ascendis Pharma Investigational Site
Tomsk, , Russia
Ascendis Pharma Investigational Site
Ufa, , Russia
Ascendis Pharma Investigational Site
Vologda, , Russia
Ascendis Pharma Investigational Site
Voronezh, , Russia
Ascendis Pharma Investigational Site
Izmir, , Turkey (Türkiye)
Ascendis Pharma Investigational Site
Melikgazi, , Turkey (Türkiye)
Ascendis Pharma Investigational Site
Trabzon, , Turkey (Türkiye)
Ascendis Pharma Investigational Site
Kharkiv, , Ukraine
Ascendis Pharma Investigational Site
Kyiv, , Ukraine
Ascendis Pharma Investigational Site
Kyiv, , Ukraine
Ascendis Pharma Investigational Site
Odesa, , Ukraine
Countries
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References
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Thornton PS, Maniatis AK, Aghajanova E, Chertok E, Vlachopapadopoulou E, Lin Z, Song W, Christoffersen ED, Breinholt VM, Kovalenko T, Giorgadze E, Korpal-Szczyrska M, Hofman PL, Karpf DB, Shu AD, Beckert M. Weekly Lonapegsomatropin in Treatment-Naive Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3184-3195. doi: 10.1210/clinem/dgab529.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001145-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TransCon hGH CT-301
Identifier Type: -
Identifier Source: org_study_id
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