Ngenla Subcutaneous Injection Special Investigation

NCT ID: NCT05602766

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-06

Study Completion Date

2029-04-06

Brief Summary

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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

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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.

Conditions

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Growth Hormone Deficiency Without Epiphyseal Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NGENLA (Somatrogon)

Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)

NGENLA (Somatrogon)

Intervention Type DRUG

Dosage, Frequency: Refer to the latest package insert.

Interventions

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NGENLA (Somatrogon)

Dosage, Frequency: Refer to the latest package insert.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Registration criteria

1. Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
2. 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.
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C0311011

To obtain contact information for a study center near you, click here.

Other Identifiers

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C0311011

Identifier Type: -

Identifier Source: org_study_id

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