An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Recruiting at 3 trial locations

Overseen By Stephanie Harrison

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Target PharmaSolutions, Inc.

Disqualifiers: HIV, Liver transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Inclusion

Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis

Exclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Phase

Data collection and analysis of patients with CHB infection managed in usual clinical practice

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Tenofovir Alafenamide (TAF)

How Is the Trial Designed?

Group I: tenofovir alafenamide Experimental Treatment 0 Interventions

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

Tenofovir Alafenamide (TAF) is already approved in United States, European Union for the following indications:

Approved in United States as Vemlidy for:

• Chronic hepatitis B virus (HBV) infection
• HIV-1 infection

Approved in European Union as Vemlidy for:

• Chronic hepatitis B virus (HBV) infection
• HIV-1 infection

Who Is Running the Clinical Trial?

Target PharmaSolutions, Inc.

Lead Sponsor

Trials

17

Recruited

5,667,000+