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NCT02311894 · ClinicalTrials.gov registry record · Phase 4
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
A Phase 4 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT02311894 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 82 participants.
The verdict
NCT02311894, a Phase 4 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.
Interventions
- DRUG Somatropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2015-03-31 |
| Est. Completion | 2017-11-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02311894
The ClinicalTrials.gov registry entry for NCT02311894 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Somatropin is the first listed.
NCT02311894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02311894 about?
NCT02311894 is a clinical study titled "A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency". This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profil...
What is the current status of trial NCT02311894?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2015-03-31. Estimated completion is 2017-11-08.
What interventions are being tested in trial NCT02311894?
The interventions under investigation include: Somatropin (DRUG).
Who is sponsoring clinical trial NCT02311894?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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