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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

NCT ID: NCT03344458

Last Updated: 2024-05-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-19

Study Completion Date

2023-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Deficiency, Pediatric Endocrine System Diseases Hormone Deficiency Pituitary Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants will receive TransCon hGH
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TransCon hGH

Once weekly subcutaneous injection of TransCon hGH

Group Type EXPERIMENTAL

TransCon hGH

Intervention Type DRUG

Once weekly subcutaneous injection of TransCon hGH

Interventions

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TransCon hGH

Once weekly subcutaneous injection of TransCon hGH

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascendis Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Ascendis Pharma Investigational Site

Los Angeles, California, United States

Site Status

Ascendis Pharma Investigational Site

Orange, California, United States

Site Status

Ascendis Pharma Investigational Site

Sacramento, California, United States

Site Status

Ascendis Pharma Investigational Site

Centennial, Colorado, United States

Site Status

Ascendis Pharma Investigational Site

Jacksonville, Florida, United States

Site Status

Ascendis Pharma Investigational Site

Orlando, Florida, United States

Site Status

Ascendis Pharma Investigational Site

Tallahassee, Florida, United States

Site Status

Ascendis Pharma Investigational Site

Saint Paul, Minnesota, United States

Site Status

Ascendis Pharma Investigational Site

Jackson, Mississippi, United States

Site Status

Ascendis Pharma Investigational Site

Lebanon, New Hampshire, United States

Site Status

Ascendis Pharma Investigational Site

Mineola, New York, United States

Site Status

Ascendis Pharma Investigational Site

New York, New York, United States

Site Status

Ascendis Pharma Investigational Site

Cleveland, Ohio, United States

Site Status

Ascendis Pharma Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Ascendis Pharma Investigational Site

Portland, Oregon, United States

Site Status

Ascendis Pharma Investigational Site

Portland, Oregon, United States

Site Status

Ascendis Pharma Investigational Site

Dallas, Texas, United States

Site Status

Ascendis Pharma Investigational Site

Fort Worth, Texas, United States

Site Status

Ascendis Pharma Investigational Site

Charlottesville, Virginia, United States

Site Status

Ascendis Pharma Investigational Site

Norfolk, Virginia, United States

Site Status

Ascendis Pharma Investigational Site

Tacoma, Washington, United States

Site Status

Ascendis Pharma Investigational Site

Yerevan, , Armenia

Site Status

Ascendis Pharma Investigational Site

Clayton, Victoria, Australia

Site Status

Ascendis Pharma Investigational Site

Minsk, , Belarus

Site Status

Ascendis Pharma Investigational Site

Varna, , Bulgaria

Site Status

Ascendis Pharma Investigational Site

Tbilisi, , Georgia

Site Status

Ascendis Pharma Investigational Site

Athens, , Greece

Site Status

Ascendis Pharma Investigational Site

Auckland, , New Zealand

Site Status

Ascendis Pharma Investigational Site

Gdansk, , Poland

Site Status

Ascendis Pharma Investigational Site

Warsaw, , Poland

Site Status

Ascendis Pharma Investigational Site

Izhevsk, , Russia

Site Status

Ascendis Pharma Investigational Site

Krasnoyarsk, , Russia

Site Status

Ascendis Pharma Investigational Site

Moscow, , Russia

Site Status

Ascendis Pharma Investigational Site

Saint Petersburg, , Russia

Site Status

Ascendis Pharma Investigational Site

Saratov, , Russia

Site Status

Ascendis Pharma Investigational Site

Ufa, , Russia

Site Status

Ascendis Pharma Investigational Site

Vologda, , Russia

Site Status

Ascendis Pharma Investigational Site

Voronezh, , Russia

Site Status

Ascendis Pharma Investigational Site

Kharkiv, , Ukraine

Site Status

Ascendis Pharma Investigational Site

Kyiv, , Ukraine

Site Status

Ascendis Pharma Investigational Site

Odesa, , Ukraine

Site Status

Countries

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United States Armenia Australia Belarus Bulgaria Georgia Greece New Zealand Poland Russia Ukraine

References

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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 PS. Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results. J Clin Endocrinol Metab. 2022 Jun 16;107(7):e2680-e2689. doi: 10.1210/clinem/dgac217.

Reference Type RESULT
PMID: 35428884 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9202697/

Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results.

Other Identifiers

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2017-003410-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TransCon hGH CT-301EXT

Identifier Type: -

Identifier Source: org_study_id

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