- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344458
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)
October 10, 2023 updated by: Ascendis Pharma A/S
enliGHten: A Multicenter, 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 Clinical Trial
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 300 children (males and females) with GHD will be included.
All study participants will receive TransCon hGH.
This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
298
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yerevan, Armenia, 0075
- Ascendis Pharma Investigational Site
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Victoria
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Clayton, Victoria, Australia, 3168
- Ascendis Pharma Investigational Site
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Minsk, Belarus, 220020
- Ascendis Pharma Investigational Site
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Varna, Bulgaria, 9010
- Ascendis Pharma Investigational Site
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Tbilisi, Georgia, 0159
- Ascendis Pharma Investigational Site
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Athens, Greece, 11527
- Ascendis Pharma Investigational Site
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Auckland, New Zealand, 1010
- Ascendis Pharma Investigational Site
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Gdańsk, Poland, 80-952
- Ascendis Pharma Investigational Site
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Warsaw, Poland, 02-691
- Ascendis Pharma Investigational Site
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Izhevsk, Russian Federation, 426009
- Ascendis Pharma Investigational Site
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Krasnoyarsk, Russian Federation, 660022
- Ascendis Pharma Investigational Site
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Moscow, Russian Federation, 117036
- Ascendis Pharma Investigational Site
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Saint Petersburg, Russian Federation, 194100
- Ascendis Pharma Investigational Site
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Saratov, Russian Federation, 410054
- Ascendis Pharma Investigational Site
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Ufa, Russian Federation, 450008
- Ascendis Pharma Investigational Site
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Vologda, Russian Federation, 160022
- Ascendis Pharma Investigational Site
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Voronezh, Russian Federation, 394024
- Ascendis Pharma Investigational Site
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Kharkiv, Ukraine, 61093
- Ascendis Pharma Investigational Site
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Kyiv, Ukraine, 01021
- Ascendis Pharma Investigational Site
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Odesa, Ukraine, 65031
- Ascendis Pharma Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Ascendis Pharma Investigational Site
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California
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Los Angeles, California, United States, 90048
- Ascendis Pharma Investigational Site
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Orange, California, United States, 92868
- Ascendis Pharma Investigational Site
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Sacramento, California, United States, 95821
- Ascendis Pharma Investigational Site
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Colorado
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Centennial, Colorado, United States, 80112
- Ascendis Pharma Investigational Site
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Florida
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Jacksonville, Florida, United States, 32207
- Ascendis Pharma Investigational Site
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Orlando, Florida, United States, 32806
- Ascendis Pharma Investigational Site
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Tallahassee, Florida, United States, 32308
- Ascendis Pharma Investigational Site
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- Ascendis Pharma Investigational Site
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Mississippi
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Jackson, Mississippi, United States, 39216
- Ascendis Pharma Investigational Site
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Ascendis Pharma Investigational Site
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New York
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Mineola, New York, United States, 11501
- Ascendis Pharma Investigational Site
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New York, New York, United States, 10029
- Ascendis Pharma Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Ascendis Pharma Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Ascendis Pharma Investigational Site
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Oregon
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Portland, Oregon, United States, 97239
- Ascendis Pharma Investigational Site
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Portland, Oregon, United States, 97227
- Ascendis Pharma Investigational Site
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Texas
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Dallas, Texas, United States, 75390
- Ascendis Pharma Investigational Site
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Fort Worth, Texas, United States, 76104
- Ascendis Pharma Investigational Site
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Virginia
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Charlottesville, Virginia, United States, 22908
- Ascendis Pharma Investigational Site
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Norfolk, Virginia, United States, 23507
- Ascendis Pharma Investigational Site
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Washington
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Tacoma, Washington, United States, 98405
- Ascendis Pharma Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 IRB/HREC/IEC
Exclusion Criteria:
- 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 (in regards 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TransCon hGH
Once weekly subcutaneous injection of TransCon hGH
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Once weekly subcutaneous injection of TransCon hGH
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]
Time Frame: Up to 4 years
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Long-term safety and tolerability of weekly TransCon hGH treatment
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Up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Annualized height velocity (HV) with long-term dosing of weekly TransCon hGH treatment
Time Frame: Up to 4 years
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Up to 4 years
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Proportion of subjects with IGF-1 standard deviation score (SDS) in the normal range of 0.0 to +2.0 with long-term dosing of weekly TransCon hGH treatment
Time Frame: Up to 4 years
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Up to 4 years
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Change in height standard deviation scores with long-term dosing of weekly TransCon hGH treatment
Time Frame: Up to 4 years
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Up to 4 years
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Incidence of antibodies against TransCon hGH with long-term dosing of weekly TransCon hGH treatment
Time Frame: Up to 4 years
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Up to 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael Beckert, MD, Ascendis Pharma A/S
- Study Director: Aimee D Shu, MD, Ascendis Pharma, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2017
Primary Completion (Actual)
February 21, 2023
Study Completion (Actual)
February 21, 2023
Study Registration Dates
First Submitted
November 14, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TransCon hGH CT-301EXT
- 2017-003410-20 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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