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NCT04638153 · ClinicalTrials.gov registry record · Phase 2
A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT04638153 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 60 participants.
The verdict
NCT04638153, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Approximately 63 participants will be randomized to one of three doses to receive Recifercept either * Low Dose * Medium Dose * High Dose Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 \& then Month 2, 3 6, 9 \& 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements \& patient/caregiver quality of life questionnaires Participants will received treatment with Recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study. A PK cohort will include 12 participants who will randomly receive a single dose of 3 mg/kg of Phase 2 study (process 1c) formulation and a single dose of 3 mg/kg of the proposed Phase 3 (process 2) study formulation in a cross over study. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.
Interventions
- BIOLOGICAL Recifercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04638153
The ClinicalTrials.gov registry entry for NCT04638153 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Recifercept is the first listed.
NCT04638153 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04638153 about?
NCT04638153 is a clinical study titled "A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia". Approximately 63 participants will be randomized to one of three doses to receive Recifercept either * Low Dose * Medium Dose * High Dose Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 \& then Month 2, 3 6, 9 \& 12. Assessments include safety, blood sampling, physi...
What is the current status of trial NCT04638153?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-12-02. Estimated completion is 2023-03-27.
What interventions are being tested in trial NCT04638153?
The interventions under investigation include: Recifercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT04638153?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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