An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 4, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Profile of patients with chronic HBV infection as measured by a review of concurrent medications, co-morbidities, medical history, staging of liver disease, and additional available clinical results.[ Time Frame: Three year retrospective review. ]

Additional results may include AFP, serology results (HBsAg, HBeAg, Anti-HBe, HBV DNA, HBV genotype and precore mutation, HDV) and radiology/histology reports (liver biopsy grade/stage, FibroScan®, MRE, ultrasound).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Efficacy of chronic HBV treatments as indicated by HBV DNA suppression measurements.[ Time Frame: Three year retrospective review. ]
Efficacy will also be measured via ALT normalization, HBeAg loss, HBsAg loss, HBeAg and HBsAg seroconversion, development of HCC or evidence of hepatic decompensation.
Safety of chronic HBV treatments on renal function as assessed by serum creatinine.[ Time Frame: Three year retrospective review. ]
Renal function will also be measured via eGFRCG, proteinuria, albuminuria, serum phosphorus.
Safety of chronic HBV treatments on bone density as assessed by DEXA scan.[ Time Frame: Three year retrospective review. ]
Bone density will also be measured via medical history of osteopenia, osteoporosis, fractures.
Safety of chronic HBV treatments as measured by co-morbidities and adverse events.[ Time Frame: Three year retrospective review. ]
Safety will be assessed by reviewing medical history for evidence of adverse events, such as cardiovascular disease, diabetes mellitus, hypertension, hyperlipidemia.

Descriptive Information

Brief Title ^ICMJE

An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

Official Title ^ICMJE

An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

Brief Summary

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of HBV with TAF and other oral therapies by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to TAF.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: TAF
Patients who are using TAF

Study Arms

: tenofovir alafenamide
Patients with a medication history of tenofovir alafenamide (TAF).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

January 2020

Estimated Primary Completion Date

January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Male or female patients, age ≥18 years - On a stable antiviral therapy regimen for hepatitis B as determined by treating physician Exclusion - Inability to provide written informed consent/assent - Known coinfection with hepatitis Delta - Known history of Human Immunodeficiency Virus (HIV)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Target PharmaSolutions, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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