Versartis International Trial in Adults With Long-Acting Growth Hormone
- Registration Number
- NCT02526420
- Lead Sponsor
- Versartis Inc.
- Brief Summary
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
- Detailed Description
A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
- 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.
- Subjects with diabetes mellitus or inadequate glucose control
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort C: Somavaratan in Women on Estrogen somavaratan Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age) Cohort A: Somavaratan in Older Adults somavaratan Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \>= 35 years of age Cohort B: Somavaratan in Younger Adults somavaratan Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \< 35 years of age
- Primary Outcome Measures
Name Time Method Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams 5 months Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval ) 5 months To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration) 5 months To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration
- Secondary Outcome Measures
Name Time Method Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs) 5 months To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers 5 months To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Trial Locations
- Locations (18)
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Therapeutic Research Institute of Orange County
🇺🇸Laguna Hills, California, United States
Charite-Universitätsmedizin
🇩🇪Berlin, Germany
AMCR Institute Inc.
🇺🇸Escondido, California, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Queen Elizabeth Hospital
🇬🇧Birmingham, B152gw, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, East Yorkshire, Hu3 2rw, United Kingdom
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Endocrine Associates of Dallas
🇺🇸Plano, Texas, United States
The Christie NHS Foundation Trust
🇬🇧Manchester, M20 4bx, United Kingdom
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Universitätsklinikum Essen
🇩🇪Essen, Germany
Stanford University
🇺🇸Stanford, California, United States
Palm Research Center
🇺🇸Las Vegas, Nevada, United States
William Harvey Research Institute
🇬🇧London, Ec1m 6bq, United Kingdom