Hepatitis BNCT03692897
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
An observational study of Hepatitis B and Hepatitis, run by Target PharmaSolutions, Inc. at 31 sites in 2 countries.
Trial summary
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Hepatitis, Liver Diseases
- What is being tested?
- All approved therapies for the treatment of Chronic Hepatitis B (CHB)
- How many people
- 1,708 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 11 Oct 2018to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 5,000 adult Chronic Hepatitis B (CHB) patients in the US and Canada; the first 500 patients enrolled were patients in the US with a medical history of tenofovir alafenamide (TAF) use for the treatment of chronic HBV.
Who may be able to join
- Male or female patients, age ≥18 years
- Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis
Who cannot join
- Inability to provide written informed consent
- Known history of Human Immunodeficiency Virus (HIV)
- History of liver transplantation
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Consultative Gastroenterology
Atlanta, Georgia, 30308
Atlanta Gastroenterology
Atlanta, Georgia, 30342
Mercy Medical Center
Baltimore, Maryland, 21202
UNC Liver Center
Chapel Hill, North Carolina, 27599
Rush Universtiy Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Dreamwork Medical, PLLC
Flushing, New York, 11354
University of Florida
Gainesville, Florida, 32610-0272
Asian Pacific Liver Center at Coalition of Inclusive Medicine
Los Angeles, California, 90020
Northwell Health Center for Liver Diseases and Transplantation
Manhasset, New York, 11030
University of Miami, Schiff Center for Liver Disease
Miami, Florida, 33136
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Yale University Digestive Diseases
New Haven, Connecticut, 06520
NYU Langone Health
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Digestive and Liver Disease Specialist
Norfolk, Virginia, 23502
California Liver Research Institute
Pasadena, California, 91105
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446
Stanford University
Redwood City, California, 94063
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
Virginia Commonwealth University
Richmond, Virginia, 23298
UC Davis GI/Hepatology Clinical Trials Unit
Sacramento, California, 95817
Silicon Valley Research Institute
San Jose, California, 95128
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB 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 antiviral treatments used in clinical practice.
- Conditions
- Hepatitis B, Hepatitis, Liver Diseases
- Being tested
- All approved therapies for the treatment of Chronic Hepatitis B (CHB)
- Medical subject headings
- Hepatitis B, Hepatitis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All approved therapies for the treatment of Chronic Hepatitis B (CHB)Other
All approved therapies for the treatment of Chronic Hepatitis B (CHB).
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural history of CHB: Characteristics of CHB infection
Measured: Up to 10 years
Natural history of CHB: Participant demographics
Measured: Up to 10 years
Natural history of CHB: Treatment use
Measured: Up to 10 years
Natural history of CHB: Treatment response
Measured: Up to 10 years
Time point of clinical response
Measured: Every 6 months for 10 years
Natural history of CHB: Disease progression
Measured: Up to 10 years
Adverse event frequency and severity
Measured: Up to 10 years
Secondary outcomes (1)
Reasons for treatment discontinuation
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start11 Oct 2018
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Why it stopped: Study Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692897
- Sponsor's protocol ID
- TARGET-HBV
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2018
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernstein DE, Trinh HN, Schiff ER, Smith CI, Mospan AR, Zink RC, Fried MW, Lok AS. Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV. Dig Dis Sci. 2022 Jun;67(6):2637-2645. doi: 10.1007/s10620-021-07033-y. Epub 2021 May 31.
PubMed 34059991
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
- ClinicalTrials.gov ID
- NCT03692897
- Acronym / sponsor ID
- TARGET-HBV
- Conditions
- Hepatitis B, Hepatitis, Liver Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study Closure
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB 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 antiviral treatments used in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 5,000 adult Chronic Hepatitis B (CHB) patients in the US and Canada; the first 500 patients enrolled were patients in the US with a medical history of tenofovir alafenamide (TAF) use for the treatment of chronic HBV.
Key inclusion criteria (2 listed)
- Male or female patients, age ≥18 years
- Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis
Key exclusion criteria (3 listed)
- Inability to provide written informed consent
- Known history of Human Immunodeficiency Virus (HIV)
- History of liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All approved therapies for the treatment of Chronic Hepatitis B (CHB)All approved therapies for the treatment of Chronic Hepatitis B (CHB). | Other | – |
Primary outcome
Natural history of CHB: Characteristics of CHB infection
Time frame: Up to 10 years
Natural history of CHB: Participant demographics
Time frame: Up to 10 years
Natural history of CHB: Treatment use
Time frame: Up to 10 years
Natural history of CHB: Treatment response
Time frame: Up to 10 years
Time point of clinical response
Time frame: Every 6 months for 10 years
Natural history of CHB: Disease progression
Time frame: Up to 10 years
Adverse event frequency and severity
Time frame: Up to 10 years
1 secondary outcome
Reasons for treatment discontinuation
Time frame: Up to 10 years
Results and safety
The study was stopped early (reason given: Study Closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 34059991Bernstein DE, Trinh HN, Schiff ER, Smith CI, Mospan AR, Zink RC, Fried MW, Lok AS. Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV. Dig Dis Sci. 2022 Jun;67(6):2637-2645. doi: 10.1007/s10620-021-07033-y. Epub 2021 May 31.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis B
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis, run by Target PharmaSolutions, Inc. at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study Closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of CHB: Characteristics of CHB infection (time frame: Up to 10 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.