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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 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.

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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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2020-09-14
Est. Completion 2028-12-01
Phase Phase 4

Sponsor

Mercy Medical Center

13 total trials

What the Registry Record Tells You About NCT04588077

The ClinicalTrials.gov registry entry for NCT04588077 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (15% lower). The listed sponsor is Mercy Medical Center, which has 13 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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