Use of TDF in Patients With Inactive Chronic Hepatitis B Infection
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|ClinicalTrials.gov Identifier: NCT02600117|
Recruitment Status : Enrolling by invitation
First Posted : November 9, 2015
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: Tenofovir disoproxil fumarate||Phase 3|
Hepatitis B virus (HBV) infection is a major worldwide health problem. The course of the majority of patients with inactive chronic hepatitis B is usually benign; therefore, the current treatment guidelines recommend not treating these patients. However, recent evidence suggests that the prognosis of these inactive carrier is not exactly benign. For instance, patients may develop liver cancer despite their inactive carrier state. Also, approximately 20-30% of patients with inactive chronic hepatitis B may undergo spontaneous reactivation of hepatitis over time. Multiple episodes of reactivation or sustained reactivation can cause progressive liver damage and even liver decompensation. However, until there are data to support that treatment with oral antivirals can alter the outcome of these patients, they will remain untreated. Potent oral antivirals have been shown to suppress HBV DNA and normalize liver enzymes in patients with active chronic hepatitis B infection. With continued long-term treatment, some of these patients have gone on to clear hepatitis B surface antigen and develop hepatitis B surface antibody. Therefore, it is possible that the same oral antivirals can have the same effect in patients with inactive chronic hepatitis B, but in a shorter duration of treatment. This study will explore the possible use of tenofovir disoproxil fumarate in controlling HBV DNA and promoting hepatitis B surface antigen seroconversion in patients with inactive chronic hepatitis B.
After completion of all initial investigations, patients will be started on TDF 300mg daily. Patients will be reviewed at 6 monthly intervals as per standard of care. At each clinic visit, patients will have blood tests including complete blood count, renal function, electrolytes, liver enzyme and liver function tests, as well as HBV serology including quantitative HBsAg and HBV DNA. Patients will also receive an abdominal ultrasound, fibroscan and fibrotest on an annual basis. Treatment will be stopped when sAg+ve seroconverts to sAb+ve or at the end of 3 years whichever comes earlier.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Tenofovir Disoproxil Fumarate (TDF) in the Management of Patients With Inactive Chronic Hepatitis B (CHB) Infection|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||October 2022|
Tenofovir disoproxil fumarate
300 mg, orally, once a day for 3 years or when sAg+ve seroconverts to sAb+ve whichever comes earlier
Drug: Tenofovir disoproxil fumarate
300 mg, oral, once a day
Other Name: Viread
- Seroconversion from hepatitis B surface antigen positive to hepatitis B surface antibody positive [ Time Frame: Three years ]Positive hepatitis B surface antibody result will indicate recovery from chronic hepatitis B virus infection.
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): NCT02600117
|University Health Network - Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Florence Wong, MD||University Health Network -Toronto General Hospital|