Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02968004|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2016
Results First Posted : June 25, 2021
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Growth Hormone Deficiency||Drug: MOD-4023 Drug: Somatropin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2022|
Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
Once weekly subcutaneous injection using pre-filled pen device.
Other Name: Somatrogon
Active Comparator: Genotropin
Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
Once daily subcutaneous injection of Genotropin using pre-filled pen device.
Other Name: Genotropin
- Annual Height Velocity [ Time Frame: 52 weeks ]Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
- Height Velocity at 6 Months [ Time Frame: After 6 months of treatment ]Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.
- Change in Height Standard Deviation Score (SDS) [ Time Frame: After 6 and 12 months ]Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.
- Change in Bone Maturation (BM) [ Time Frame: 52 weeks ]Annual change in bone age measurements as per Gruelich-Pyle method
- Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS) [ Time Frame: Baseline and at 12 months ]Via central lab analysis
- Device [ Time Frame: 6 weeks ]Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA
- Device [ Time Frame: 1 week ]Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968004
|Study Director:||Tony Cruz||Sponsor GmbH|