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

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ClinicalTrials.gov Identifier: NCT03692897
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

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.

Condition or disease Intervention/treatment
Hepatitis B Hepatitis Liver Diseases Other: TAF

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
tenofovir alafenamide
Patients with a medication history of tenofovir alafenamide (TAF).
Other: TAF
Patients who have a medication history of TAF




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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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
The study will include adults who have a positive HBV diagnosis (currently HBsAg+) or are on antiviral therapy for hepatitis B as determined by the treating physician. The first cohort of participants to be enrolled are those with a medical history of tenofovir alafenamide (TAF) for HBV management. A cohort of additional adult patients treated with NAs who have not been exposed to TAF may also be enrolled, however this will occur in a subsequent phase of this study.
Criteria

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)

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
Contact: Chloe Katz, MPH, MSHS (984) 234-0268 ext 214 ckatz@targetpharmasolutions.com

Locations
United States, California
California Liver Research Institute Recruiting
Pasadena, California, United States, 91105
Contact: Stephanie Tang    626-795-5769      
Sponsors and Collaborators
Target PharmaSolutions, Inc.

Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03692897     History of Changes
Other Study ID Numbers: TARGET-HBV
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Liver Diseases
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections