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

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ClinicalTrials.gov Identifier: NCT03692897
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Hepatitis B Hepatitis Liver Diseases Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)
    All approved therapies for the treatment of Chronic Hepatitis B (CHB).

Outcome Measures
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Primary Outcome Measures :
  1. Natural history of CHB: Characteristics of CHB infection [ Time Frame: Up to 10 years ]
  2. Natural history of CHB: Participant demographics [ Time Frame: Up to 10 years ]
  3. Natural history of CHB: Treatment use [ Time Frame: Up to 10 years ]
  4. Natural history of CHB: Treatment response [ Time Frame: Up to 10 years ]
  5. Time point of clinical response [ Time Frame: Every 6 months for 10 years ]
  6. Natural history of CHB: Disease progression [ Time Frame: Up to 10 years ]
  7. Adverse event frequency and severity [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. Reasons for treatment discontinuation [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Patients enrolled in TARGET-HBV may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion

  1. Male or female patients, age ≥18 years
  2. Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis

Exclusion

  1. Inability to provide written informed consent
  2. Known history of Human Immunodeficiency Virus (HIV)
  3. History of liver transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692897


Contacts
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Contact: Stephanie Harrison 919-930-2792 sharrison@targetrwe.com
Contact: Deirdre Ciampa (984) 234-0268 ext 2685 dciampa@targetrwe.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03692897    
Other Study ID Numbers: TARGET-HBV
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Infections
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic