Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03379506 · ClinicalTrials.gov registry record · Phase 2
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT03379506 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 57 participants.
The verdict
NCT03379506, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination \[FDC\] tablet containing elbasvir \[EBR\] 50 mg and grazoprevir \[GZR\] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infected participants who are 3 to \<18 years of age. Within each age cohort (Cohort 1: 12 to \<18 years of age; Cohort 2: 7 to \<12 years of age; and Cohort 3: 3 to \<7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric granules instead of a tablet.
Interventions
- DRUG Placebo
- DRUG EBR/GZR FDC Tablet
- DRUG Grazoprevir Oral Granules
- DRUG Elbasvir Oral Granules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03379506
The ClinicalTrials.gov registry entry for NCT03379506 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 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 4 interventions - of which Placebo is the first listed.
NCT03379506 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03379506 about?
NCT03379506 is a clinical study titled "Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)". The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination \[FDC\] tablet containing elbasvir \[EBR\] 50 mg and grazoprevir \[GZR\] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric hepatitis C virus (HCV)-infect...
What is the current status of trial NCT03379506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2018-01-25. Estimated completion is 2020-07-23.
What interventions are being tested in trial NCT03379506?
The interventions under investigation include: Placebo (DRUG), EBR/GZR FDC Tablet (DRUG), Grazoprevir Oral Granules (DRUG), Elbasvir Oral Granules (DRUG).
Who is sponsoring clinical trial NCT03379506?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.