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NCT04588077 · ClinicalTrials.gov registry record · Phase 4
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
A Phase 4 study of Cirrhosis, Liver and Hepatitis B, sponsored by Mercy Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04588077: Recruiting Phase 4 study of Cirrhosis, Liver and Hepatitis B, sponsored by Mercy Medical Center.
NCT04588077 is a Phase 4 study of Cirrhosis, Liver and Hepatitis B that is actively recruiting participants, run by Mercy Medical Center. The registered enrollment target is 200 participants, below the 236-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04588077, a Phase 4 study of Cirrhosis, Liver and Hepatitis B, is actively recruiting participants, sponsored by Mercy Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
Primary Outcome
The rates of seroconversion is defined as an HBsAg antibody concentration ≥ 10 mIU/ml.
Conditions Studied
Interventions
- BIOLOGICAL Heplisav-B Injectable Product, 2-dose regimen
- BIOLOGICAL Heplisav-B Injectable Product, 3-dose regimen
Study Locations (1)
Maryland
- Mercy Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 4 |
What NCT04588077 shows while recruiting
NCT04588077 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 236-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (15% lower).
The record links to 3 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 2 interventions - of which Heplisav-B Injectable Product, 2-dose regimen is the first listed.
NCT04588077 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04588077 about?
NCT04588077 is a clinical study titled "Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis". Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.
What is the current status of trial NCT04588077?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2020-09-14. Estimated completion is 2028-12-01.
What conditions does trial NCT04588077 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Hepatitis B, Chronic Liver Disease.
What interventions are being tested in trial NCT04588077?
The interventions under investigation include: Heplisav-B Injectable Product, 2-dose regimen (BIOLOGICAL), Heplisav-B Injectable Product, 3-dose regimen (BIOLOGICAL).
Who is sponsoring clinical trial NCT04588077?
This trial is sponsored by Mercy Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04588077 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis, Liver
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04588077's enrollment target sits among peer trials
200 12th of 34 higher than 21 of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver 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.
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