Ngenla Subcutaneous Injection Special Investigation

Pfizer

Status

Active, not recruiting

Conditions

Growth Hormone Deficiency Without Epiphyseal Closure

Treatments

Drug: NGENLA (Somatrogon)

Study type

Observational

Funder types

Industry

Identifiers

NCT05602766

C0311011

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients who satisfy all of the registration criteria are subject to this study.

Registration criteria

Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.