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NCT03182907 · ClinicalTrials.gov registry record · Phase 3
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT03182907 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 148 participants.
The verdict
NCT03182907, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to \<18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab.
Interventions
- DRUG Placebo
- BIOLOGICAL Bezlotoxumab
- DRUG Antibacterial drug treatment (ABD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03182907
The ClinicalTrials.gov registry entry for NCT03182907 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03182907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03182907 about?
NCT03182907 is a clinical study titled "Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)". The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to \<18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary h...
What is the current status of trial NCT03182907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2018-03-27. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT03182907?
The interventions under investigation include: Placebo (DRUG), Bezlotoxumab (BIOLOGICAL), Antibacterial drug treatment (ABD) (DRUG).
Who is sponsoring clinical trial NCT03182907?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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