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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344458
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency, Pediatric Endocrine System Diseases Hormone Deficiency Pituitary Diseases Drug: TransCon hGH Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All study participants will receive TransCon hGH
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: TransCon hGH
Once weekly subcutaneous injection of TransCon hGH
Drug: TransCon hGH
Once weekly subcutaneous injection of TransCon hGH




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability] [ Time Frame: Up to 4 years ]
    Long-term safety and tolerability of weekly TransCon hGH treatment


Secondary Outcome Measures :
  1. Annualized height velocity (HV) with long-term dosing of weekly TransCon hGH treatment [ Time Frame: Up to 4 years ]
  2. 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 ]
  3. Change in height standard deviation scores with long-term dosing of weekly TransCon hGH treatment [ Time Frame: Up to 4 years ]
  4. Incidence of antibodies against TransCon hGH with long-term dosing of weekly TransCon hGH treatment [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344458


Locations
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United States, Alabama
Ascendis Pharma Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
Ascendis Pharma Investigational Site
Los Angeles, California, United States, 90048
Ascendis Pharma Investigational Site
Orange, California, United States, 92868
Ascendis Pharma Investigational Site
Sacramento, California, United States, 95821
United States, Colorado
Ascendis Pharma Investigational Site
Centennial, Colorado, United States, 80112
United States, Florida
Ascendis Pharma Investigational Site
Jacksonville, Florida, United States, 32207
Ascendis Pharma Investigational Site
Orlando, Florida, United States, 32806
Ascendis Pharma Investigational Site
Tallahassee, Florida, United States, 32308
United States, Minnesota
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States, 55102
United States, Mississippi
Ascendis Pharma Investigational Site
Jackson, Mississippi, United States, 39216
United States, New Hampshire
Ascendis Pharma Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
Ascendis Pharma Investigational Site
Mineola, New York, United States, 11501
Ascendis Pharma Investigational Site
New York, New York, United States, 10029
United States, Ohio
Ascendis Pharma Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Ascendis Pharma Investigational Site
Portland, Oregon, United States, 97227
Ascendis Pharma Investigational Site
Portland, Oregon, United States, 97239
United States, Texas
Ascendis Pharma Investigational Site
Dallas, Texas, United States, 75390
Ascendis Pharma Investigational Site
Fort Worth, Texas, United States, 76104
United States, Virginia
Ascendis Pharma Investigational Site
Charlottesville, Virginia, United States, 22908
Ascendis Pharma Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Ascendis Pharma Investigational Site
Tacoma, Washington, United States, 98405
Armenia
Ascendis Pharma Investigational Site
Yerevan, Armenia, 0075
Australia, Victoria
Ascendis Pharma Investigational Site
Clayton, Victoria, Australia, 3168
Belarus
Ascendis Pharma Investigational Site
Minsk, Belarus, 220020
Bulgaria
Ascendis Pharma Investigational Site
Varna, Bulgaria, 9010
Georgia
Ascendis Pharma Investigational Site
Tbilisi, Georgia, 0159
Greece
Ascendis Pharma Investigational Site
Athens, Greece, 11527
New Zealand
Ascendis Pharma Investigational Site
Auckland, New Zealand, 1010
Poland
Ascendis Pharma Investigational Site
Gdańsk, Poland, 80-952
Ascendis Pharma Investigational Site
Warsaw, Poland, 02-691
Russian Federation
Ascendis Pharma Investigational Site
Izhevsk, Russian Federation, 426009
Ascendis Pharma Investigational Site
Krasnoyarsk, Russian Federation, 660022
Ascendis Pharma Investigational Site
Moscow, Russian Federation, 117036
Ascendis Pharma Investigational Site
Saint Petersburg, Russian Federation, 194100
Ascendis Pharma Investigational Site
Saratov, Russian Federation, 410054
Ascendis Pharma Investigational Site
Ufa, Russian Federation, 450008
Ascendis Pharma Investigational Site
Vologda, Russian Federation, 160022
Ascendis Pharma Investigational Site
Voronezh, Russian Federation, 394024
Ukraine
Ascendis Pharma Investigational Site
Kharkiv, Ukraine, 61093
Ascendis Pharma Investigational Site
Kyiv, Ukraine, 01021
Ascendis Pharma Investigational Site
Odesa, Ukraine, 65031
Sponsors and Collaborators
Ascendis Pharma A/S
Investigators
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Study Director: Michael Beckert, MD Ascendis Pharma A/S
Study Director: Aimee D Shu, MD Ascendis Pharma, Inc.
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Responsible Party: Ascendis Pharma A/S
ClinicalTrials.gov Identifier: NCT03344458    
Other Study ID Numbers: TransCon hGH CT-301EXT
2017-003410-20 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascendis Pharma A/S:
Human Growth Hormone
hGH
GHD
rhGH
Pediatric Growth Hormone Deficiency
Long Acting Growth Hormone
Somatropin
Prodrug
Growth Failure
Growth Hormone Replacement Therapy
Sustained Release Growth Hormone
Growth Hormone Deficiency
TransCon GH
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Pituitary Diseases
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism