Primary outcomeLeast squares mean· 12 months
Annual Height Velocity
| Group | Value (cm/year) | Spread |
|---|---|---|
| Somavaratan | 9.43 | 0.28 |
| rhGH | 10.70 | 0.48 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataLong-Acting Growth Hormone in Children Compared to Daily rhGH
Short name VELOCITY
NCTNCT02339090 (opens ClinicalTrials.gov in a new tab)Other id14VR4
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 138 participants (actual)
- Sponsor
- Versartis Inc. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- 26 Aug 2015
- Primary completion
- 23 Aug 2017
- Completion
- 23 Aug 2017
- First posted
- 15 Jan 2015 (estimated)
- Last update posted
- 30 Dec 2022
- Conditions
- Growth Disorders
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.
Interventions
- SomavaratanDrug
- rhGHDrug
Arms2
Experimental
Somavaratan
Participants will receive somavaratan 3.5 milligrams (mg)/kilogram (kg) subcutaneous (SC) bolus injection twice monthly for 12 months.
Active comparator
rhGH
Participants will receive commercially available rhGH (genotropin) 34 micrograms (μg)/kg once daily SC bolus injection for 12 months.
Primary outcomes1
Outcomes the sponsor listed as primary.
Annual Height Velocity
Time frame · 12 months
Registry description
Height measured without shoes in triplicate by stadiometer. Annual height velocity was calculated as (height at Month 12 - height at Baseline)/(Month 12 Date - Baseline Date) \* 365.25, where height was expressed as centimeters (cm) so that height velocity is expressed as centimeters per year (cm/yr). Annual height velocity after 12 months continuous treatment with either somavaratan or daily rhGH has been reported. Missing data was imputed using last observation carried forward. Least square (LS) mean was calculated using analysis of covariance (ANCOVA) model.
Secondary outcomes(7)
Change From Baseline in Height Standard Deviation Score (SDS) at Month 12
Time frame · Baseline, Month 12
Registry description
Height SDS was determined using the Center for Disease Control (CDC) Clinical Growth Charts; 2000. The SD score was calculated as the participant's height value minus the mean divided by the standard deviation (SD). The mean and the SD vary depending on the age and sex of the participant. Mean change from baseline in height SDS at Month 12 is presented.
Change From Baseline in Bone Age Relative to Chronological Age at Month 12, as Assessed by Central Reader
Time frame · Baseline, Month 12
Registry description
Bone age was assessed from a radiograph of the left hand and wrist by central reader.
Change From Baseline in Body Mass Index (BMI) at Month 12
Time frame · Baseline, Month 12
Registry description
The BMI is a person's weight in kilograms (kg) divided by the square of height in meters.
Change From Baseline in Body Weight at Month 12
Time frame · Baseline, Month 12
Registry description
Body weight measured in light clothing and without shoes.
Change From Baseline in Insulin-like Growth Factor 1 (IGF-I) SDS at Month 12
Time frame · Baseline, Month 12
Registry description
The SD score was calculated as the actual value of IGF-I minus mean reference value of IGF-1 divided by reference standard deviation of IGF-I. The mean and the SD vary depending on the age and sex of the participant. Change in IGF-I level (SD score) at Month 12 from Baseline was assessed. A higher score reflects a better outcome.
Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) at Month 12
Time frame · Baseline, Month 12
Number of Participants With Adverse Events (AEs)
Time frame · Baseline up to Month 12
Registry description
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Month 12
Change From Baseline in Height Standard Deviation Score (SDS) at Month 12
| Group | Value (SD score) | Spread |
|---|---|---|
| Somavaratan | 0.8 | 0.53 |
| rhGH | 1.0 | 0.51 |
Secondary outcomeMean· Baseline, Month 12
Change From Baseline in Bone Age Relative to Chronological Age at Month 12, as Assessed by Central Reader
| Group | Value (months) | Spread |
|---|---|---|
| Somavaratan | 1.1 | 0.47 |
| rhGH | 1.3 | 0.55 |
Secondary outcomeMean· Baseline, Month 12
Change From Baseline in Body Mass Index (BMI) at Month 12
| Group | Value (kg/m^2) | Spread |
|---|---|---|
| Somavaratan | 1.1 | 0.86 |
| rhGH | -0.1 | 0.95 |
Secondary outcomeMean· Baseline, Month 12
Change From Baseline in Body Weight at Month 12
| Group | Value (kg) | Spread |
|---|---|---|
| Somavaratan | 4.9 | 1.87 |
| rhGH | 3.8 | 1.64 |
Secondary outcomeMean· Baseline, Month 12
Change From Baseline in Insulin-like Growth Factor 1 (IGF-I) SDS at Month 12
| Group | Value (SD score) | Spread |
|---|---|---|
| Somavaratan | 0.9 | 0.99 |
| rhGH | 1.8 | 0.72 |
Secondary outcomeMedian· Baseline, Month 12
Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) at Month 12
| Group | Value (nanomoles (nmol)/milliliter (mL)) | Spread |
|---|---|---|
| Somavaratan | 32.2 | 30.2 |
| rhGH | 49.8 | 19.1 |
Secondary outcomeCount of participants· Baseline up to Month 12
Number of Participants With Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Somavaratan | 80 |
| rhGH | 22 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SomavaratanParticipants received somavaratan 3.5 mg/kg SC bolus injection twice monthly for 12 months. | 0 / 104 | 6 / 104 | 59 / 104 |
| rhGHParticipants received commercially available rhGH (genotropin) 34 μg/kg once daily SC bolus injection for 12 months. | 0 / 32 | 0 / 32 | 16 / 32 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 3 Years up to 11 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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 growth hormone deficiency (GHD) as documented by two or more growth hormone (GH) stimulation test results ≤ 10.0 ng/mL.
* Height standard deviation score (SDS) ≤ -2.0 at screening.
* Weight for Stature ≥ 10th percentile.
* Insulin-like growth factor-I (IGF-I) SDS ≤ -1.0 at screening.
* Delayed bone age (≥ 6 months).
Exclusion Criteria:
* Prior treatment with any growth promoting agent
* History of, or concurrent significant disease (for example, 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
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