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Also known as hGH-ViaDerm™ System (hGH or somatropin)
hGH-ViaDerm System · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| hGH-ViaDerm™ System (hGH or somatropin) | DRUG | transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day) |
| hGH-ViaDerm™ System | DEVICE | The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin). The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system. |
Inclusion Criteria: Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both 1. Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria: * Three or more additional pituitary hormone deficiencies, based on well documented medical ...
The hGH-ViaDerm System is an investigational drug-device combination being developed by Teva Pharmaceutical Industries Limited for growth hormone deficiency. It is designed to deliver hGH, also known as somatropin, and has been studied in adults with GH deficiency. It remains in clinical development and is not an approved product.
The hGH-ViaDerm System is being developed for the treatment of growth hormone deficiency. Its only recorded clinical study enrolled adults with GH deficiency, aged 20 years and older. The program is investigational, so the system is not approved for commercial use in this or any other indication.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of the hGH-ViaDerm System. Teva sponsored the Phase 1 study of the system in adults with growth hormone deficiency. No other developer or partner is associated with the program in the available record.
The hGH-ViaDerm System is in Phase 1 development. Its single recorded trial, NCT00455260, was a Phase 1 study and has been completed. The program is investigational and has not been approved by the FDA or any other regulator based on the available record.
One clinical trial of the hGH-ViaDerm System is on record: NCT00455260, titled A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm System in Adults With GH-Deficiency. It was a completed Phase 1 study that enrolled 60 adults, was randomized and double blind, and used an uncontrolled design.
The hGH-ViaDerm System is also known as the hGH-ViaDerm System (hGH or somatropin). The hGH component is somatropin, the same recombinant human growth hormone used in other growth hormone deficiency therapies, but the ViaDerm System refers specifically to Teva's investigational delivery system for administering it.