An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection
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|ClinicalTrials.gov Identifier: NCT03692897|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2018
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment|
|Hepatitis B Hepatitis Liver Diseases||Other: TAF|
|Study Type :||Observational|
|Actual Enrollment :||514 participants|
|Official Title:||An Observational Study of Patients Undergoing Therapy for Chronic Hepatitis B (HBV) Infection|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Patients with a medication history of tenofovir alafenamide (TAF).
Patients who have a medication history of TAF
- 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).
- 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.
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