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NCT03344458 Clinical Trial

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

Endocrine System Diseases Clinical Trial

— enliGHten  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03344458
Other study ID # TransCon hGH CT-301EXT
Secondary ID 2017-003410-20
Status Completed
Phase Phase 3
First received
Last updated
Start date December 19, 2017
Est. completion date February 21, 2023

Study information
Verified date April 2024
Source Ascendis Pharma A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 298
Est. completion date February 21, 2023
Est. primary completion date February 21, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
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) 6. Pregnancy 7. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TransCon hGH
Once weekly subcutaneous injection of TransCon hGH

Locations
Country Name City State
Armenia Ascendis Pharma Investigational Site Yerevan
Australia Ascendis Pharma Investigational Site Clayton Victoria
Belarus Ascendis Pharma Investigational Site Minsk
Bulgaria Ascendis Pharma Investigational Site Varna
Georgia Ascendis Pharma Investigational Site Tbilisi
Greece Ascendis Pharma Investigational Site Athens
New Zealand Ascendis Pharma Investigational Site Auckland
Poland Ascendis Pharma Investigational Site Gdansk
Poland Ascendis Pharma Investigational Site Warsaw
Russian Federation Ascendis Pharma Investigational Site Izhevsk
Russian Federation Ascendis Pharma Investigational Site Krasnoyarsk
Russian Federation Ascendis Pharma Investigational Site Moscow
Russian Federation Ascendis Pharma Investigational Site Saint Petersburg
Russian Federation Ascendis Pharma Investigational Site Saratov
Russian Federation Ascendis Pharma Investigational Site Ufa
Russian Federation Ascendis Pharma Investigational Site Vologda
Russian Federation Ascendis Pharma Investigational Site Voronezh
Ukraine Ascendis Pharma Investigational Site Kharkiv
Ukraine Ascendis Pharma Investigational Site Kyiv
Ukraine Ascendis Pharma Investigational Site Odesa
United States Ascendis Pharma Investigational Site Birmingham Alabama
United States Ascendis Pharma Investigational Site Centennial Colorado
United States Ascendis Pharma Investigational Site Charlottesville Virginia
United States Ascendis Pharma Investigational Site Cleveland Ohio
United States Ascendis Pharma Investigational Site Dallas Texas
United States Ascendis Pharma Investigational Site Fort Worth Texas
United States Ascendis Pharma Investigational Site Jackson Mississippi
United States Ascendis Pharma Investigational Site Jacksonville Florida
United States Ascendis Pharma Investigational Site Lebanon New Hampshire
United States Ascendis Pharma Investigational Site Los Angeles California
United States Ascendis Pharma Investigational Site Mineola New York
United States Ascendis Pharma Investigational Site New York New York
United States Ascendis Pharma Investigational Site Norfolk Virginia
United States Ascendis Pharma Investigational Site Oklahoma City Oklahoma
United States Ascendis Pharma Investigational Site Orange California
United States Ascendis Pharma Investigational Site Orlando Florida
United States Ascendis Pharma Investigational Site Portland Oregon
United States Ascendis Pharma Investigational Site Portland Oregon
United States Ascendis Pharma Investigational Site Sacramento California
United States Ascendis Pharma Investigational Site Saint Paul Minnesota
United States Ascendis Pharma Investigational Site Tacoma Washington
United States Ascendis Pharma Investigational Site Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Ascendis Pharma A/S

Countries where clinical trial is conducted

United States,  Armenia,  Australia,  Belarus,  Bulgaria,  Georgia,  Greece,  New Zealand,  Poland,  Russian Federation,  Ukraine, 

References & Publications (1)

Maniatis AK, Casella SJ, Nadgir UM, Hofman PL, Saenger P, Chertock ED, Aghajanova EM, Korpal-Szczyrska M, Vlachopapadopoulou E, Malievskiy O, Chaychenko T, Cappa M, Song W, Mao M, Mygind PH, Smith AR, Chessler SD, Komirenko AS, Beckert M, Shu AD, Thornton — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability] Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment Up to Week 208
Secondary Annualized Height Velocity by Visit Annualized height velocity (AHV) by visit with long-term dosing of weekly lonapegsomatropin treatment Up to Week 208
Secondary IGF-1 SDS by Visit Insulin-like Growth Factor-1 (IGF-1) standard deviation score (SDS) by visit with long-term dosing of weekly lonapegsomatropin treatment at Week 13, Week 52, Week 104, Week 156, and Week 208. IGF-1 SDS is the number of standard deviations above or below the mean IGF-1 level for a child of the same age and sex. The target range for IGF-1 SDS was 0 to +2. An IGF-1 SDS of 0 represents the population mean. If the IGF-1 SDS is < 0, then the negative score indicates an IGF-1 below the mean IGF-1 for a child of the same age and sex. If the IGF-1 SDS is > 0, then the positive score indicates an IGF-1 above the mean IGF-1 for a child of the same age and sex. A positive score of IGF-1 SDS indicates a better outcome. Up to Week 208
Secondary Height SDS - Change From Baseline Change in Height Standard Deviation Score (SDS) from baseline with long-term dosing of weekly lonapegsomatropin treatment at Week 13, Week 52, Week 104, Week 156, and Week 208. Height SDS is the number of standard deviations above or below the mean height for age and sex. A Standard Deviation Score of 0 equals the population mean. If the Height SDS is < 0, then the negative score indicates a height below the mean height for a child of the same age and sex. If the Height SDS is > 0, then the positive score indicates a height above the mean height for a child of the same age and sex. A positive change from baseline in Height SDS indicates improved outcomes. Up to Week 208
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