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



Status:Recruiting
Conditions:Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:1 - 18
Updated:1/12/2019
Start Date:December 19, 2017
End Date:December 2021
Contact:Michael Beckert, MD
Email:mb@ascendispharma.com
Phone:+49 172-155-2596

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
22
sites
Lebanon, New Hampshire 03756
Phone: 650-461-4835
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Birmingham, Alabama 35233
Phone: 650-461-4835
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Centennial, Colorado 80112
Phone: 650-461-4835
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charlottesville, Virginia 22908
Phone: 650-461-4835
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cleveland, Ohio 44195
Phone: 650-461-4835
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dallas, Texas 75390
Phone: 650-461-4835
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
Phone: 650-461-4835
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Jackson, Mississippi 39216
Phone: 650-461-4835
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32207
Phone: 650-461-4835
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Los Angeles, California 90048
Phone: 650-461-4835
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Mineola, New York 11501
Phone: 650-461-4835
?
mi
from
Mineola, NY
Click here to add this to my saved trials
New York, New York 10029
Phone: 650-461-4835
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
Phone: 650-461-4835
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Phone: 650-461-4835
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
Phone: 650-461-4835
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 650-461-4835
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Portland, Oregon 97227
Phone: 650-461-4835
?
mi
from
Portland, OR
Click here to add this to my saved trials
Sacramento, California 95821
Phone: 650-461-4835
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
Phone: 650-461-4835
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Tacoma, Washington 98405
Phone: 650-461-4835
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tallahassee, Florida 32308
Phone: 650-461-4835
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Yerevan,
Phone: +49 172-155-2596
?
mi
from
Yerevan,
Click here to add this to my saved trials