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NCT02167113 · ClinicalTrials.gov registry record

Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay

A clinical trial of Hepatitis B， Chronic, sponsored by Hologic.

Completed
Registry status
331
Enrollment target
20
Study locations

NCT02167113 is a study of Hepatitis B， Chronic that has completed, run by Hologic. The registered enrollment target is 331 participants, below the 551-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02167113, a study of Hepatitis B， Chronic, has completed, sponsored by Hologic.

COMPLETED
Registry status
331 participants
Enrollment target
20
Study locations

Study Summary

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.

Conditions Studied

Hepatitis B， Chronic

Study Locations (20)

California

  • Advanced Rx Clinical Research - Garden Grove
  • High Desert Gastroenterology - Lancaster
  • Kaiser Permanente Los Angeles Medical Center - Los Angeles
  • Stanford University Medical Center - Palo Alto
  • Inland Empire Liver Foundation - Rialto
  • Kaiser Permanente - San Diego
  • Kaiser Foundation Hospital - San Francisco
  • San Jose Gastroenterology - San Jose
  • South Bay Gastroenterology Medical Group - Torrance

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • Newton-Wellesley Hospital - Newton
  • The Research Institute - Springfield

Arizona

  • Banner Health Good Samaritan - Phoenix
  • Dignity Health - St. Joseph's Hospital - Phoenix

Georgia

  • Digestive Healthcare of Georgia - Atlanta
  • Gastrointestinal Specialists of Georgia - Marietta

Maryland

  • Mercy Medical Center - Baltimore
  • Digestive Disease Associates, PA - Catonsville

Connecticut

  • Yale University School of Medicine - New Haven

Florida

  • Schiff Center for Liver Disease - Miami

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2014-03
Est. Completion 2018-01-23

Sponsor

Hologic

21 total trials

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What the Registry Record Tells You About NCT02167113

The ClinicalTrials.gov registry entry for NCT02167113 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 551-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (40% lower). The listed sponsor is Hologic, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis B， Chronic appearing as the primary indexed condition, and to 0 interventions.

NCT02167113 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT02167113 about?

NCT02167113 is a clinical study titled "Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay". This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an...

What is the current status of trial NCT02167113?

This trial is currently completed. The enrollment target is 331 participants. The study started on 2014-03. Estimated completion is 2018-01-23.

What conditions does trial NCT02167113 study?

This clinical trial studies the following conditions: Hepatitis B， Chronic.

Who is sponsoring clinical trial NCT02167113?

This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02167113 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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

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.