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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: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT04638153 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AE is defined as an AE with onset dat
Interventions
- BIOLOGICAL Recifercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 2 |
Why NCT04638153 stopped before completion
NCT04638153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Recifercept is the first listed.
NCT04638153 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04638153's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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