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

Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay

NCT02167113•Hologic, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject is chronically infected with HBV.The subject is treatment naïve and is initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in the FDA approved label
•The subject will be considered treatment naïve if he/she had \<12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
•The subject is at least 18 years of age at the time of enrollment
•Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
•The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)

Exclusion Criteria

•Subject is in one of the following patient populations:
•* Acute HBV infection
•* Patients who are HBV immune tolerant
•* Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection
•* Solid organ or bone marrow transplant recipients
•* Renal failure or dialysis
•* Evidence or history of hepatic decompensation
•* Evidence or history of hepatocellular carcinoma
•Underlying liver disease other than HBV
•Receiving chemotherapy, immunosuppressive agents
+2 more criteria

Locations (90)

Banner Health Good Samaritan

Phoenix, Arizona, United States

Dignity Health - St. Joseph's Hospital

Phoenix, Arizona, United States

Advanced Rx Clinical Research

Garden Grove, California, United States

High Desert Gastroenterology

Lancaster, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Kaiser Permanente

San Diego, California, United States

Kaiser Foundation Hospital

San Francisco, California, United States

San Jose Gastroenterology

San Jose, California, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

February 1, 2016

Completion Date

January 23, 2018

Last Updated

August 1, 2018

Enrollment

331

ACTUAL participants

Conditions

Hepatitis B, Chronic

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels