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: 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

Sponsors

Lead Sponsor: Ascendis Pharma A/S

Source Ascendis Pharma A/S
Brief 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.

Overall Status Active, not recruiting
Start Date 2017-12-19
Completion Date 2026-12-01
Primary Completion Date 2026-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability] Up to 4 years
Secondary Outcome
Measure Time Frame
Annualized height velocity (HV) with long-term dosing of weekly TransCon hGH treatment Up to 4 years
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 Up to 4 years
Change in height standard deviation scores with long-term dosing of weekly TransCon hGH treatment Up to 4 years
Incidence of antibodies against TransCon hGH with long-term dosing of weekly TransCon hGH treatment Up to 4 years
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: TransCon hGH

Description: Once weekly subcutaneous injection of TransCon hGH

Arm Group Label: TransCon hGH

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

1 Year

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Ascendis Pharma Investigational Site | Birmingham, Alabama, 35233, United States
Ascendis Pharma Investigational Site | Los Angeles, California, 90048, United States
Ascendis Pharma Investigational Site | Orange, California, 92868, United States
Ascendis Pharma Investigational Site | Sacramento, California, 95821, United States
Ascendis Pharma Investigational Site | Centennial, Colorado, 80112, United States
Ascendis Pharma Investigational Site | Jacksonville, Florida, 32207, United States
Ascendis Pharma Investigational Site | Orlando, Florida, 32806, United States
Ascendis Pharma Investigational Site | Tallahassee, Florida, 32308, United States
Ascendis Pharma Investigational Site | Saint Paul, Minnesota, 55102, United States
Ascendis Pharma Investigational Site | Jackson, Mississippi, 39216, United States
Ascendis Pharma Investigational Site | Lebanon, New Hampshire, 03756, United States
Ascendis Pharma Investigational Site | Mineola, New York, 11501, United States
Ascendis Pharma Investigational Site | New York, New York, 10029, United States
Ascendis Pharma Investigational Site | Cleveland, Ohio, 44195, United States
Ascendis Pharma Investigational Site | Oklahoma City, Oklahoma, 73104, United States
Ascendis Pharma Investigational Site | Portland, Oregon, 97227, United States
Ascendis Pharma Investigational Site | Portland, Oregon, 97239, United States
Ascendis Pharma Investigational Site | Dallas, Texas, 75390, United States
Ascendis Pharma Investigational Site | Fort Worth, Texas, 76104, United States
Ascendis Pharma Investigational Site | Charlottesville, Virginia, 22908, United States
Ascendis Pharma Investigational Site | Norfolk, Virginia, 23507, United States
Ascendis Pharma Investigational Site | Tacoma, Washington, 98405, United States
Ascendis Pharma Investigational Site | Yerevan, 0075, Armenia
Ascendis Pharma Investigational Site | Clayton, Victoria, 3168, Australia
Ascendis Pharma Investigational Site | Minsk, 220020, Belarus
Ascendis Pharma Investigational Site | Varna, 9010, Bulgaria
Ascendis Pharma Investigational Site | Tbilisi, 0159, Georgia
Ascendis Pharma Investigational Site | Athens, 11527, Greece
Ascendis Pharma Investigational Site | Auckland, 1010, New Zealand
Ascendis Pharma Investigational Site | Gdańsk, 80-952, Poland
Ascendis Pharma Investigational Site | Warsaw, 02-691, Poland
Ascendis Pharma Investigational Site | Izhevsk, 426009, Russian Federation
Ascendis Pharma Investigational Site | Krasnoyarsk, 660022, Russian Federation
Ascendis Pharma Investigational Site | Moscow, 117036, Russian Federation
Ascendis Pharma Investigational Site | Saint Petersburg, 194100, Russian Federation
Ascendis Pharma Investigational Site | Saratov, 410054, Russian Federation
Ascendis Pharma Investigational Site | Ufa, 450008, Russian Federation
Ascendis Pharma Investigational Site | Vologda, 160022, Russian Federation
Ascendis Pharma Investigational Site | Voronezh, 394024, Russian Federation
Ascendis Pharma Investigational Site | Kharkiv, 61093, Ukraine
Ascendis Pharma Investigational Site | Kyiv, 01021, Ukraine
Ascendis Pharma Investigational Site | Odesa, 65031, Ukraine
Location Countries

Armenia

Australia

Belarus

Bulgaria

Georgia

Greece

New Zealand

Poland

Russian Federation

Ukraine

United States

Verification Date

2021-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: TransCon hGH

Type: Experimental

Description: Once weekly subcutaneous injection of TransCon hGH

Acronym enliGHten
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: All study participants will receive TransCon hGH

Primary Purpose: Treatment

Masking: None (Open Label)

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