Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Sponsor Hologic, Inc.
Start date March 2014
End date September 2018
Trial size 331 participants
Trial identifier NCT02167113, V10434-HBVQPS-CSP-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Association between virologic response at Week 12 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
time frame: Week 48 (from start of therapy)
Association between virologic response at Week 24 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
time frame: Week 48 (from start of therapy)

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication) - Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hologic, Inc..