A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

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

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-20

Study Completion Date

2033-03-31

Brief Summary

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The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

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Detailed Description

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Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on SKYTROFA (Lonapegsomatropin)Treatment

SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection

No intervention

Intervention Type DRUG

No intervention

Interventions

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No intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Paediatric patients with GHD who are on treatment with lonapegsomatropin
* Patients being clinically managed in Europe or the USA
* Appropriate written informed consent/assent as applicable for the age of the patient
* Patients willing to comply with follow-up requirements of the study

Exclusion Criteria

* Patients participating in any interventional clinical trial for short stature
* Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
* Patients for whom treatment with lonapegsomatropin is contraindicated
* Patients with closed epiphyses
* Patients with active malignant tumours
* Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
* Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No