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NCT01146808 · ClinicalTrials.gov registry record · Phase 1

Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

A Phase 1 study, sponsored by Columbia University.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01146808 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 16 participants.

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The verdict

NCT01146808, a Phase 1 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.

Interventions

  • DRUG Adefovir dipivoxil and hepatitis B vaccination

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-03
Est. Completion 2012-09
Phase Phase 1

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT01146808

The ClinicalTrials.gov registry entry for NCT01146808 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Adefovir dipivoxil and hepatitis B vaccination is the first listed.

NCT01146808 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01146808 about?

NCT01146808 is a clinical study titled "Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver". The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). T...

What is the current status of trial NCT01146808?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-03. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01146808?

The interventions under investigation include: Adefovir dipivoxil and hepatitis B vaccination (DRUG).

Who is sponsoring clinical trial NCT01146808?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

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

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.