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Completed

NCT Number: NCT02339090

Long-Acting Growth Hormone in Children Compared to Daily rhGH

The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

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Key information

Conditions

Growth Disorders Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Failure to Thrive Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Signs and Symptoms

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study is designed as a pivotal study to compare the safety and efficacy of a selected dose regimen of somavaratan to daily rhGH. The study is a randomized, multi-center, open label study of 12 months duration. The primary endpoint is height velocity at 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somavaratan

Drug

Somavaratan will be administered per dose and schedule specified in the arm description.

Other names: Long-acting recombinant human growth hormone, VRS-317

rhGH

Drug

rhGH will be administered per dose and schedule specified in the arm description.

Other names: daily growth hormone, recombinant growth hormone therapy

Primary outcomes

  1. Annual Height Velocity

    Time frame: 12 months

    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

  1. Change From Baseline in Height Standard Deviation Score (SDS) at Month 12

    Time frame: Baseline, Month 12

    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.

  2. Change From Baseline in Bone Age Relative to Chronological Age at Month 12, as Assessed by Central Reader

    Time frame: Baseline, Month 12

    Bone age was assessed from a radiograph of the left hand and wrist by central reader.

  3. Change From Baseline in Body Mass Index (BMI) at Month 12

    Time frame: Baseline, Month 12

    The BMI is a person's weight in kilograms (kg) divided by the square of height in meters.

  4. Change From Baseline in Body Weight at Month 12

    Time frame: Baseline, Month 12

    Body weight measured in light clothing and without shoes.

  5. Change From Baseline in Insulin-like Growth Factor 1 (IGF-I) SDS at Month 12

    Time frame: Baseline, Month 12

    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.

  6. Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) at Month 12

    Time frame: Baseline, Month 12

  7. Number of Participants With Adverse Events (AEs)

    Time frame: Baseline up to Month 12

    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'.

Sponsors and collaborators

Lead sponsor

Versartis Inc.

Industry

Registry information

Official study 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

Acronym: VELOCITY

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2015
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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