|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02339090 |
|
Date of registration:
|
07/01/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH
VELOCITY |
|
Scientific title:
|
Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency. |
|
Date of first enrolment:
|
August 24, 2015 |
|
Target sample size:
|
136 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02339090 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Belgium
|
Canada
|
Netherlands
|
Poland
|
Sweden
|
United States
| | |
|
Contacts
|
|
Name:
|
Will Charlton, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sponsor GmbH |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Chronological Age = 3.0 years and = 10.0 (girls) and = 11.0 (boys).
- Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in
boys.
- Diagnosis of GHD as documented by two or more GH stimulation test results = 10.0
ng/mL.
- Height SD score = -2.0 at screening.
- Weight for Stature = 10th percentile.
- IGF-I SD score = -1.0 at screening.
- Delayed bone age (= 6 months).
Exclusion Criteria:
- Prior treatment with any growth promoting agent
- History of or concurrent significant disease (e.g. diabetes, cystic fibrosis, renal
insufficiency).
- Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
or confirmed diagnosis of a named syndrome.
- A diagnosis of Attention Deficit Hyperactivity Disorder.
- Daily use of anti-inflammatory doses of glucocorticoid.
- Prior history of leukemia, lymphoma, sarcoma or cancer.
- Treatment with an investigational drug in the 30 days prior to screening.
- Known allergy to constituents of the study drug formulation.
- Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
screening.
- Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants.
- Significant abnormality in screening laboratory studies
Age minimum:
3 Years
Age maximum:
11 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Growth Disorders
|
|
Intervention(s)
|
|
Drug: Daily rhGH
|
|
Drug: somavaratan
|
|
Primary Outcome(s)
|
|
Efficacy (Annual height velocity)
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Safety as measured by he number of patients with adverse events, concomitant medications, safety labs, vital signs, physical exams, and repeat dose immunogenicity.
[Time Frame: 12 Months]
|
|
Pharmacodynamics (IGF-I and IGFBP-3 responses to study drug administration)
[Time Frame: 12 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|