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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 : Active, not recruiting
First Posted : October 2, 2018
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Tracking Information
First Submitted Date September 4, 2018
First Posted Date October 2, 2018
Last Update Posted Date October 15, 2021
Actual Study Start Date October 11, 2018
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2021)
  • 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 ]
Original Primary Outcome Measures
 (submitted: October 1, 2018)
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).
Change History
Current Secondary Outcome Measures
 (submitted: October 12, 2021)
Reasons for treatment discontinuation [ Time Frame: Up to 10 years ]
Original Secondary Outcome Measures
 (submitted: October 1, 2018)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
Official Title An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Hepatitis B
  • Hepatitis
  • Liver Diseases
Intervention Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)
All approved therapies for the treatment of Chronic Hepatitis B (CHB).
Study Groups/Cohorts Not Provided
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. 2021 May 31. doi: 10.1007/s10620-021-07033-y. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 12, 2021)
5000
Original Estimated Enrollment
 (submitted: October 1, 2018)
500
Estimated Study Completion Date January 2026
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03692897
Other Study ID Numbers TARGET-HBV
Has Data Monitoring Committee No
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 Target PharmaSolutions, Inc.
Study Sponsor Target PharmaSolutions, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Target PharmaSolutions, Inc.
Verification Date October 2021