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

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合作者:
信息的提供 (责任方):
September 4, 2018
October 2, 2018
October 2, 2018
October 2018
January 2020   (主要结果测量的最终数据收集日期)
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).

与当前相同
  • 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.
 
An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection
An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection

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.

Observational
分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:
  • Other: TAF
    Patients who are using TAF
  • : tenofovir alafenamide
    Patients with a medication history of tenofovir alafenamide (TAF).
 
Not yet recruiting
500
与当前相同
January 2020
January 2020   (主要结果测量的最终数据收集日期)
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)
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: Undecided
Target PharmaSolutions, Inc.
:
September 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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