Approval Probability
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Saizen E-Device · 1 trial · 1 indication
Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.
| Arm | Type | Description |
|---|---|---|
| Saizen® E-Device | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Saizen® E-Device | DEVICE | Saizen® (recombinant human growth hormone \[r-hGH\]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. |
Inclusion Criteria: 1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age \[SGA\] according to the local SmPC) 2. Written informed consent must be obtained from the parent...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | Somapacitan |
| Ascendis Pharma A/S | ASND | 1 | PHASE3 | Lonapegsomatropin, Somatropin Pen Injector |
Saizen E-Device is used for growth disorders. It is an investigational product being developed by Merck KGaA for the treatment of growth disorders. The product is currently in Phase 3 clinical development, though it is not yet approved for use.
Saizen E-Device is developed by Merck KGaA, a company traded under the ticker MKGAF. The product is being studied for the treatment of growth disorders and is currently in Phase 3 clinical development.
Saizen E-Device is in Phase 3 clinical development. It is an investigational product for growth disorders and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with 20 participants enrolled.
Saizen E-Device has one completed Phase 3 clinical trial, identified as NCT00450190, titled 'Saizen® E-Device User Trial'. This trial enrolled 20 participants with growth disorders and was not randomized, double-blind, or controlled.
Saizen E-Device is a specific formulation or delivery device version of the Saizen product. While Saizen is a brand name for somatropin, Saizen E-Device refers to the device used for administration. The product is being developed for growth disorders.