Ngenla Subcutaneous Injection Special Investigation

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05602766
• Collaborator: (none)
• Enrollment: 229
• Anticipated Duration (Months): 65.4

Study Details

Study Description

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.

We are seeking participants 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 monitor their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.

Participants will take part in the study from the date of first Ngenla treatment until November 30, 2027.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency Without Epiphyseal Closure	Drug: NGENLA (Somatrogon)

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
• Anticipated Enrollment: 229 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ngenla® Subcutaneous Injection Special Investigation
• Anticipated Study Start Date: Dec 28, 2022
• Anticipated Primary Completion Date: Jun 9, 2028
• Anticipated Study Completion Date: Jun 9, 2028

Arms and Interventions

Arm	Intervention/Treatment
NGENLA (Somatrogon) Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)	Drug: NGENLA (Somatrogon); Dosage, Frequency: Refer to the latest package insert.

Outcome Measures

Primary Outcome Measures

1. The number of patients reporting Adverse Events (AEs) [up to 5 years]

2. Incidence of Glucose metabolism disorders per exposure period [up to 5 years]

3. Incidence of Neoplasm per exposure period [up to 5 years]

4. Annual growth rate (cm/year) [up to 5 years]

5. Growth rate standard deviation score (SDS) for chronological age [up to 5 years]

6. Change in height SDS for chronological age and time-course of height SDS for chronological age [up to 5 years]

7. Proportion of reported Adverse Events [up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05602766
• Other Study ID Numbers: C0311011
• First Posted: Nov 2, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Growth hormone deficiency (GHD); Recombinant human growth hormone (hGH); once-weekly injection; Somatrogon

Study Results

No Results Posted as of Dec 9, 2022