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| Name | Class |
|---|---|
| Premier Research | OTHER |
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A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Somavaratan in Older Adults | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age |
|
| Cohort B: Somavaratan in Younger Adults | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age |
|
| Cohort C: Somavaratan in Women on Estrogen | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somavaratan | Drug | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams | Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams. | 5 months |
| Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval ) | 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) | 5 months |
| Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration) | 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 | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers | To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers | 5 months |
| Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Rogoff, MD, PhD | Versartis Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute Inc. | Escondido | California | 92025 | United States | ||
| Therapeutic Research Institute of Orange County |
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| Label | URL |
|---|---|
| Company Website | View source |
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To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb) |
| 5 months |
| Laguna Hills |
| California |
| 92653 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Palm Research Center | Las Vegas | Nevada | 89128 | United States |
| Endocrine Associates of Dallas | Plano | Texas | 75093 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Charite-Universitätsmedizin | Berlin | 10117 | Germany |
| Universitätsklinikum Essen | Essen | D- 45147 | 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 |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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