Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05929807
Registration number
NCT05929807
Ethics application status
Date submitted
6/06/2023
Date registered
3/07/2023
Date last updated
16/04/2024
Titles & IDs
Public title
A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia
Query!
Scientific title
A Phase 2, Multicenter, Long-Term, Open Label Extension Trial Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children and Adolescents With Achondroplasia
Query!
Secondary ID [1]
0
0
ASND0039
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AttaCH
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Achondroplasia
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TransCon CNP
Experimental: TransCon CNP 100 mcg - TransCon CNP 100 mcg delivered once weekly by subcutaneous injection
Treatment: Drugs: TransCon CNP
TransCon CNP drug product is a lyophilized powder in a single-use vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Safety and Tolerability
Query!
Assessment method [1]
0
0
Incidence of Treatment-Emergent Adverse Events
Query!
Timepoint [1]
0
0
Through trial completion, an average of 10 years
Query!
Primary outcome [2]
0
0
Height Z-scores
Query!
Assessment method [2]
0
0
Number of standard deviations
Query!
Timepoint [2]
0
0
Through trial completion, an average of 10 years
Query!
Secondary outcome [1]
0
0
Annualized Growth Velocity
Query!
Assessment method [1]
0
0
cm per year
Query!
Timepoint [1]
0
0
Through trial completion, an average of 10 years
Query!
Eligibility
Key inclusion criteria
- Written, signed informed consent of the parent(s) or legal guardian(s) of the
participant, and as required by the institutional review board/human research ethics
committee/independent ethics committee (IRB/HREC/IEC). For participants who are below
the age of consent, a written assent will be obtained in accordance with applicable
requirements as required by IRB/HREC/IEC. Upon reaching the legal age of consent,
depending on applicable requirements, these participants will be asked to give their
own written consent.
- Participants with achondroplasia who have completed a clinical trial with TransCon
CNP.
- Parent(s)/legal guardian(s) willing and able to administer weekly SC injections of
TransCon CNP and to follow the protocol.
- Considered eligible based on the safety evaluations performed for evaluating
stopping/holding rule criteria during the prior TransCon CNP clinical trial.
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
15
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Known or suspected hypersensitivity to the investigational product or related products
(trehalose, tris[hydroxymethyl]aminomethane, succinate, and methoxy polyethylene
glycol [mPEG]).
- Have received any dose of prescription medications, investigational medicinal product
(other than TransCon CNP).
- Sexually active female participants and female partners of male participants of
childbearing potential not using a highly effective form of contraceptive (including
oral, injectable, or implantable contraception, or intrauterine device (IUD)) for the
entire trial period and for 90 days post end of the trial.
- Participants with serum 25-hydroxy-vitamin D (25OHD) levels of <50 nmol/L (<20 ng/mL)
at Visit 1 must be on treatment regimen of Vitamin D supplementation.
- Any disease or condition that, in the opinion of the investigator, may make the
participant unlikely to fully complete the trial, may confound interpretation of trial
results, or may present undue risk from receiving trial treatment. This could include
family situations, complications or manifestations, or medications that might impact
safety or be considered confounding.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/06/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2039
Query!
Actual
Query!
Sample size
Target
140
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Ascendis Pharma Investigational Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Minnesota
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Montana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New York
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Texas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Wisconsin
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Linz
Query!
Country [9]
0
0
Denmark
Query!
State/province [9]
0
0
Copenhagen
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Berlin
Query!
Country [11]
0
0
Ireland
Query!
State/province [11]
0
0
Dublin
Query!
Country [12]
0
0
New Zealand
Query!
State/province [12]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Ascendis Pharma Growth Disorders A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
TransCon CNP administered once-weekly in children and adolescents with achondroplasia who
have completed a prior TransCon CNP clinical trial. Participants who complete a prior
TransCon CNP trial and meet all eligibility criteria will be invited to continue into the
long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial
treatment will be completed when the participant reaches 16 years of age for females and 18
years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment
will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years
for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur
and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is
individual for each trial participant. Visits will occur every 12-14 weeks throughout the
trial.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05929807
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Vibeke Breinholt
Query!
Address
0
0
Ascendis Pharma
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05929807
Download to PDF