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NCT00985426 · ClinicalTrials.gov registry record · Phase 3

Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

A Phase 3 study of Chronic Kidney Disease, sponsored by Dynavax Technologies Corporation.

Completed
Registry status
Phase 3
Development phase
521
Enrollment target
1
Study location

NCT00985426 is a Phase 3 study of Chronic Kidney Disease that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 521 participants, below the 3,202-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00985426, a Phase 3 study of Chronic Kidney Disease, has completed, sponsored by Dynavax Technologies Corporation.

COMPLETED
Registry status
Phase 3
Development phase
521 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL HEPLISAV-B
  • BIOLOGICAL Engerix-B

Study Locations (1)

Virginia

  • Clinical Research Associates of Tidewater - Norfolk

Trial Details

FieldValue
Enrollment Target 521 participants
Start Date 2009-09
Est. Completion 2012-01
Phase Phase 3

Sponsor

Dynavax Technologies Corporation

16 total trials

What the Registry Record Tells You About NCT00985426

The ClinicalTrials.gov registry entry for NCT00985426 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 521 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,202-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (84% lower). The listed sponsor is Dynavax Technologies Corporation, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00985426 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT00985426 about?

NCT00985426 is a clinical study titled "Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients". The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.

What is the current status of trial NCT00985426?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 2009-09. Estimated completion is 2012-01.

What conditions does trial NCT00985426 study?

This clinical trial studies the following conditions: Chronic Kidney Disease.

What interventions are being tested in trial NCT00985426?

The interventions under investigation include: Placebo (OTHER), HEPLISAV-B (BIOLOGICAL), Engerix-B (BIOLOGICAL).

Who is sponsoring clinical trial NCT00985426?

This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00985426 being conducted?

This trial has 1 study location across Virginia. 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

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.