Versartis International Trial in Adults With Long-Acting Growth Hormone
NCT ID: NCT02526420
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2015-07-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-Acting Growth Hormone in Children Compared to Daily rhGH
NCT02339090
VRS-317 in Adult Subjects With Growth Hormone Deficiency
NCT01359488
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
NCT02719990
Versartis Trial in Children to Assess Long-Acting Growth Hormone
NCT01718041
Versartis Long-Term Safety Study of Somavaratan
NCT02068521
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A: Somavaratan in Older Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \>= 35 years of age
somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Cohort B: Somavaratan in Younger Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \< 35 years of age
somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Cohort C: Somavaratan in Women on Estrogen
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects must have documented GHD during adulthood.
* Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months.
* Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months.
* Subjects receiving daily rhGH injections must washout for 14 days.
* Subjects must provide signed informed consent.
* Subjects must have a BMI (kg/m2) between 19.0 and 35.0.
Exclusion Criteria
* Subjects with untreated adrenal insufficiency.
* Subjects with free thyroxine outside the normal reference range.
* Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.
* Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class \> 2.
* Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease.
* Subjects with current papilledema.
* Subjects with a history of persistent or recurring migraines.
* Subjects with current edema (≥ CTCAE Grade 2).
* Subjects with current drug or alcohol abuse.
* Subjects with a documented history of HIV, current HBV or HCV infection
* Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix.
* Women who are pregnant or breastfeeding.
* Subjects with a significant abnormality in Screening laboratory results
23 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Premier Research Group plc
UNKNOWN
Versartis Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniela Rogoff, MD, PhD
Role: STUDY_DIRECTOR
Versartis Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AMCR Institute Inc.
Escondido, California, United States
Therapeutic Research Institute of Orange County
Laguna Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Palm Research Center
Las Vegas, Nevada, United States
Endocrine Associates of Dallas
Plano, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Charite-Universitätsmedizin
Berlin, , Germany
Universitätsklinikum Essen
Essen, , Germany
Queen Elizabeth Hospital
Birmingham, B152gw, United Kingdom
William Harvey Research Institute
London, EC1M 6BQ, United Kingdom
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2RW, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15VR7
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.