Phase
Condition
Severe Short Stature
Treatment
N/AClinical Study ID
Ages < 8 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Legally authorized representative is willing and able to provide written, signedinformed consent (with a written assent from the child when appropriate per localrequirements)
- Willing and able to comply with study protocol per investigator judgement
- Clinical diagnosis of achondroplasia (confirmed by the investigator)
- Age between 0 to 8 years old at enrollment
- Able to stand without assistance (if the child is 24 months or older)
Exclusion
Exclusion Criteria:
- Have received chronic treatment (> 3 months) of human growth hormone (hGH) or othermedicinal products intended to affect stature or body proportionality at any time
- Have received any dose of medicinal products intended to affect stature or bodyproportionality within the previous 6 months of screening
- Have received any investigational medicinal product or device intended to affectstature or body proportionality at any time
- History or presence of injury or disease of the growth plate(s), other than ACH, thataffects growth potential of long bones
- History of any bone-related surgery that affects growth potential of long bones, suchas orthopedic reconstructive surgery and osteotomy (foramen magnum decompression, andlaminectomy with full recovery are allowed with minimum of 6 months of bone healing.Limb-lengthening with full recovery is allowed with a minimum of 12 months of bonehealing.)
- Have forms of skeletal dysplasias other than achondroplasia or medical conditions thatresult in short stature or abnormal bone growth [such as severe achondroplasia withdevelopmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, growthhormone deficiency, Turner syndrome, pseudoachondroplasia. uncontrolledhypothyroidism, uncontrolled diabetes mellitus, autoimmune disease requiringcorticosteroid therapy, inflammatory bowel disease, and chronic renal insufficiency]
- History or presence of malignant disease, other than basal cell epithelioma/carcinomaor completely resected squamous skin cancer with no recurrence for 12 months permedical records
Study Design
Connect with a study center
Ascendis Pharma Investigational Site
Parkville, Victoria 3052
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Linz, 4020
AustriaSite Not Available
Ascendis Pharma Investigational Site
Edmonton, Alberta T6G-1C9
CanadaSite Not Available
Ascendis Pharma Investigational Site
Ottawa, Ontario 51H 8L1
CanadaSite Not Available
Ascendis Pharma Investigational Site
Montréal, Quebec H3T 1C5
CanadaSite Not Available
Ascendis Pharma Investigational Site
Beijing, 100045
ChinaSite Not Available
Ascendis Pharma Investigational Site
Guangzhou, 510080
ChinaSite Not Available
Ascendis Pharma Investigational Site
Hangzhou, 310053
ChinaSite Not Available
Ascendis Pharma Investigational Site
Shanghai, 20082
ChinaSite Not Available
Ascendis Pharma Investigational Site
Shenzhen, 518053
ChinaSite Not Available
Ascendis Pharma Investigational Site
Wuhan, 430030
ChinaSite Not Available
Ascendis Pharma Investigational Site
Copenhagen, Hovedstaden 2100
DenmarkSite Not Available
Ascendis Pharma Investigational Site
Paris, 75743
FranceSite Not Available
Ascendis Pharma Investigational Site
Berlin, 13353
GermanySite Not Available
Ascendis Pharma Investigational Site
Dublin, 1
IrelandSite Not Available
Ascendis Pharma Investigational Site
Milano, 20132
ItalySite Not Available
Ascendis Pharma Investigational Site
Rome, 00165
ItalySite Not Available
Ascendis Pharma Investigational Site
Auckland, 1142
New ZealandSite Not Available
Ascendis Pharma Investigational Site
Coimbra, 3000
PortugalSite Not Available
Ascendis Pharma Investigational Site
Barcelona, 08035
SpainSite Not Available
Ascendis Pharma Investigational Site
Esplugues De Llobregat, 8950
SpainSite Not Available
Ascendis Pharma Investigational Site
Madrid, 28046
SpainSite Not Available
Ascendis Pharma Investigational Site
Vitoria-Gasteiz, 1008
SpainSite Not Available
Ascendis Pharma Investigational Site
Lausanne, 1005
SwitzerlandSite Not Available
Ascendis Pharma Investigational Site
Glasgow, G51 4TF
United KingdomSite Not Available
Ascendis Pharma Investigational Site
Liverpool, LA12 2AP
United KingdomSite Not Available
Ascendis Pharma Investigational Site
London, SE1 7EU
United KingdomSite Not Available
Ascendis Pharma Investigational Site
Little Rock, Arkansas 72211
United StatesSite Not Available
Ascendis Pharma Investigational Site
Oakland, California 94609
United StatesSite Not Available
Ascendis Pharma Investigational Site
Aurora, Colorado 80045
United StatesSite Not Available
Ascendis Pharma Investigational Site
Wilmington, Delaware 19803
United StatesSite Not Available
Ascendis Pharma Investigational Site
Atlanta, Georgia 30322
United StatesSite Not Available
Ascendis Pharma Investigational Site
Boston, Massachusetts 02115
United StatesSite Not Available
Ascendis Pharma Investigational Site
Saint Paul, Minnesota 55102
United StatesSite Not Available
Ascendis Pharma Investigational Site
Columbia, Missouri 65212
United StatesSite Not Available
Ascendis Pharma Investigational Site
Buffalo, New York 14203
United StatesSite Not Available
Ascendis Pharma Investigational Site
Houston, Texas 77030
United StatesSite Not Available
Ascendis Pharma Investigational Site
Norfolk, Virginia 23507
United StatesSite Not Available
Ascendis Pharma Investigational Site
Seattle, Washington 98105
United StatesSite Not Available
Ascendis Pharma Investigational Site
Madison, Wisconsin 53705
United StatesSite Not Available
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