Ngenla® Subcutaneous Injection Special Investigation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Incidence of Glucose metabolism disorders per exposure period
Study Overview
Brief Summary
The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
- Have GHD without epiphyseal closure and receiving Ngenla for the first time.
- Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
Detailed Description
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NGENLA (Somatrogon)
Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)
Intervention: NGENLA (Somatrogon) (Drug)
Outcomes
Primary Outcomes
Incidence of Glucose metabolism disorders per exposure period
Time Frame: up to 5 years
Growth rate standard deviation score (SDS) for chronological age
Time Frame: up to 5 years
The number of patients reporting Adverse Events (AEs)
Time Frame: up to 5 years
Incidence of Neoplasm per exposure period
Time Frame: up to 5 years
Change in height SDS for chronological age and time-course of height SDS for chronological age
Time Frame: up to 5 years
Proportion of reported Adverse Events
Time Frame: up to 5 years
Annual growth rate (cm/year)
Time Frame: up to 5 years
Secondary Outcomes
No secondary outcomes reported