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Long-Acting Growth Hormone in Children Compared to Daily rhGH

NCT ID: NCT02339090

Last Updated: 2022-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-26

Study Completion Date

2017-08-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Growth Disorders

Keywords

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VRS-317 Growth Hormone Deficiency Long Acting Recombinant Growth Hormone Long Acting Growth Hormone Pediatric Growth Hormone Deficiency Growth Hormone Replacement Therapy Versartis Xten Human Growth Hormone somavaratan growth failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somavaratan

Participants will receive somavaratan 3.5 milligrams (mg)/kilogram (kg) subcutaneous (SC) bolus injection twice monthly for 12 months.

Group Type EXPERIMENTAL

Somavaratan

Intervention Type DRUG

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

rhGH

Participants will receive commercially available rhGH (genotropin) 34 micrograms (μg)/kg once daily SC bolus injection for 12 months.

Group Type ACTIVE_COMPARATOR

rhGH

Intervention Type DRUG

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

Interventions

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Somavaratan

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

Intervention Type DRUG

rhGH

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

Intervention Type DRUG

Other Intervention Names

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Long-acting recombinant human growth hormone VRS-317 daily growth hormone recombinant growth hormone therapy

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versartis Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Will Charlton, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Countries

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Belgium Canada Netherlands Poland Sweden United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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14VR4

Identifier Type: -

Identifier Source: org_study_id