Phase
Condition
Growth Hormone Deficiencies/abnormalities
Treatment
Lonapegsomatropin
Clinical Study ID
Ages 23-81 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signing of the trial specific informed consent
Completion of the treatment period and Visit 7 assessments of trial TCH-306,including collection and upload of Visit 7 DXA scan
Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranialhypertension or diabetic retinopathy stage 2 / moderate or above
Exclusion
Exclusion Criteria:
- Diabetes mellitus if any of the following are met:
Poorly controlled diabetes, defined as HbA1C higher than 7.5% according tocentral laboratory at Visit 6 in trial TCH-306
Use of diabetes mellitus drugs other than metformin and/or dipeptidylpeptidase-4 (DPP-4) inhibitors
- Active malignant disease or history of malignancy. Exceptions are:
Resection of in situ carcinoma of the cervix uteri
Complete eradication of squamous cell or basal cell carcinoma of the skin
Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
Female who is pregnant, plans to become pregnant, or is breastfeeding
Female participant of childbearing potential (i.e., fertile, following menarche anduntil becoming post-menopausal unless permanently sterile) not willing throughoutthe trial to use contraceptives as required by local law or practice. Detailsincluded in Appendix 4/section 10.4 of the protocol
Male participant not willing throughout the trial to use contraceptives as requiredby local law or practice. Details included in Appendix 4/ section 10.4 of theprotocol
Any disease or condition that, in the judgement of the investigator, may make theparticipant unlikely to comply with the requirements of the protocol or anycondition that presents undue risk from the investigational product or trialprocedures
Study Design
Connect with a study center
Ascendis Pharma Investigational Site
Yerevan, 0075
ArmeniaSite Not Available
Ascendis Pharma Investigational Site
Saint Leonards, New South Wales 2065
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Sydney, New South Wales 2109
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Box Hill, Victoria 3128
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Fitzroy, Victoria 3065
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Parkville, Victoria 3050
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Perth, Western Australia 6009
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
Ascendis Pharma Investigational Site
Lyon, 69677
FranceSite Not Available
Ascendis Pharma Investigational Site
Marseille, 13385
FranceSite Not Available
Ascendis Pharma Investigational Site
Nantes, 44093
FranceSite Not Available
Ascendis Pharma Investigational Site
Tbilisi, 0159
GeorgiaSite Not Available
Ascendis Pharma Investigational Site
München, 80336
GermanySite Not Available
Ascendis Pharma Investigational Site
Athens, 11527
GreeceSite Not Available
Ascendis Pharma Investigational Site
Thessaloníki, 54636
GreeceSite Not Available
Ascendis Pharma Investigational Site
Haifa, 31048
IsraelSite Not Available
Ascendis Pharma Investigational Site
Petah tikva, 4941480
IsraelSite Not Available
Ascendis Pharma Investigational Site
Tel Aviv, 6423906
IsraelSite Not Available
Ascendis Pharma Investigational Site
Genova, 16132
ItalySite Not Available
Ascendis Pharma Investigational Site
Rome, 00168
ItalySite Not Available
Ascendis Pharma Investigational Site
Kobe, Hyogo 650-0047
JapanSite Not Available
Ascendis Pharma Investigational Site
Chiba, 260-8677
JapanSite Not Available
Ascendis Pharma Investigational Site
Fukuoka, 812-8582
JapanSite Not Available
Ascendis Pharma Investigational Site
Ishikawa, 920-0293
JapanSite Not Available
Ascendis Pharma Investigational Site
Kagoshima, 890-8520
JapanSite Not Available
Ascendis Pharma Investigational Site
Kawasaki, 210-0024
JapanSite Not Available
Ascendis Pharma Investigational Site
Kitakyushu, 807-8555
JapanSite Not Available
Ascendis Pharma Investigational Site
Matsumoto, 390-8510
JapanSite Not Available
Ascendis Pharma Investigational Site
Miyakojima, 534-0021
JapanSite Not Available
Ascendis Pharma Investigational Site
Nagakute, 480-1195
JapanSite Not Available
Ascendis Pharma Investigational Site
Nara, 634-8522
JapanSite Not Available
Ascendis Pharma Investigational Site
Okayama, 700-8558
JapanSite Not Available
Ascendis Pharma Investigational Site
Osaka, 550-0006
JapanSite Not Available
Ascendis Pharma Investigational Site
Shizuoka, 422-8527
JapanSite Not Available
Ascendis Pharma Investigational Site
Suita, 565-0871
JapanSite Not Available
Ascendis Pharma Investigational Site
Yamagata, 990-9585
JapanSite Not Available
Ascendis Pharma Investigational Site
Yokohama, 236-0004
JapanSite Not Available
Ascendis Pharma Investigational Site
Soeul, 06591
Korea, Republic ofSite Not Available
Ascendis Pharma Investigational Site
George Town, 10450
MalaysiaSite Not Available
Ascendis Pharma Investigational Site
Melaka, 75400
MalaysiaSite Not Available
Ascendis Pharma Investigational Site
Putrajaya, 62250
MalaysiaSite Not Available
Ascendis Pharma Investigational Site
Kraków, 31-501
PolandSite Not Available
Ascendis Pharma Investigational Site
Warszawa, 03-242
PolandSite Not Available
Ascendis Pharma Investigational Site
Wrocław, 50-367
PolandSite Not Available
Ascendis Pharma Investigational Site
Łódź, 93-338
PolandSite Not Available
Ascendis Pharma Investigational Site
Bucharest, 11868
RomaniaSite Not Available
Ascendis Pharma Investigational Site
Iaşi, 700106
RomaniaSite Not Available
Ascendis Pharma Investigational Site
Belgrade, 11000
SerbiaSite Not Available
Ascendis Pharma Investigational Site
Bratislava, 82606
SlovakiaSite Not Available
Ascendis Pharma Investigational Site
Ľubochňa, 3491
SlovakiaSite Not Available
Ascendis Pharma Investigational Site
Alicante, 3010
SpainSite Not Available
Ascendis Pharma Investigational Site
Barcelona, 8035
SpainSite Not Available
Ascendis Pharma Investigational Site
Sevilla, 41013
SpainSite Not Available
Ascendis Pharma Investigational Site
Ankara, 06560
TurkeySite Not Available
Ascendis Pharma Investigational Site
Antalya, 07070
TurkeySite Not Available
Ascendis Pharma Investigational Site
Aydın, 09010
TurkeySite Not Available
Ascendis Pharma Investigational Site
Kayseri, 38039
TurkeySite Not Available
Ascendis Pharma Investigational Site
İzmit, 41001
TurkeySite Not Available
Ascendis Pharma Investigational Site
Ivano-Frankivs'k, 76008
UkraineSite Not Available
Ascendis Pharma Investigational Site
Kyiv, 03115
UkraineSite Not Available
Ascendis Pharma Investigational Site
Vinnytsia, 21010
UkraineSite Not Available
Ascendis Pharma Investigational Site
Leeds, LS9 7TF
United KingdomSite Not Available
Ascendis Pharma Investigational Site
Phoenix, Arizona 85048
United StatesSite Not Available
Ascendis Pharma Investigational Site
Torrance, California 90509
United StatesSite Not Available
Ascendis Pharma Investigational Site
Chicago, Illinois 60611
United StatesSite Not Available
Ascendis Pharma Investigational Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Ascendis Pharma Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
Ascendis Pharma Investigational Site
Dearborn, Michigan 48126
United StatesSite Not Available
Ascendis Pharma Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
Ascendis Pharma Investigational Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Ascendis Pharma Investigational Site
Las Vegas, Nevada 89148
United StatesSite Not Available
Ascendis Pharma Investigational Site
Reno, Nevada 89511
United StatesSite Not Available
Ascendis Pharma Investigational Site
New York, New York 10017
United StatesSite Not Available
Ascendis Pharma Investigational Site
Portland, Oregon 97239
United StatesSite Not Available
Ascendis Pharma Investigational Site
Dallas, Texas 75390
United StatesSite Not Available
Ascendis Pharma Investigational Site
San Antonio, Texas 78232
United StatesSite Not Available
Ascendis Pharma Investigational Site
Seattle, Washington 98108
United StatesSite Not Available
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