A Phase 2 interventional study of Entecavir and Entecavir combined with Tenofovir Amibufenamide in Chronic Hepatitis B Virus Infection, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
The study aims to demonstrate that antiviral therapy for patients with immune tolerance of CHB. On the basis of the original antiviral therapy of entecavir, further clarify the safety and effectiveness of entecavir combined with tenofovir amibufenamide.The investigators plan to enroll about 328 hepatitis B patients,. who are in the stage of immune tolerance. These participants will be devided into two groups randomly .Group A will receive the treatment of entecavir. Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.
High HBV DNA level is an independent risk factor for liver cirrhosis and liver cancer, we know all patients with chronic hepatitis B virus infection in immune tolerance period had high viral load. So it is necessary to implement antiviral therapy for patients with chronic hepatitis B virus infection in immune tolerance period.Previous studies have found that combination of two antiviral drugs has a higher virological inhibition rate in patients with high viral load than single drug. Hence, the investigators' hypothesis is that treatment of patients with chronic hepatitis B virus infection in immune tolerance period result in higher virological inhibition rate and reduce of the risk of cirrhosis and liver cancer.
The investigators plan to enroll about 328 hepatitis B patients, who are in the stage of immune tolerance. These participants will be devided into 2 groups.Group A will receive the treatment of entecavir . Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks. Unless there are serious adverse drug reactions, the protocol cannot be adjusted within 96 weeks.
The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.
954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.
This study's planned enrollment of 238 is above the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.
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Exclusion Criteria:
Patients receive treatment with entecavir
Drug: Entecavir
Patients will receive the treatment of entecavir combined with tenofovir amibufenamide
Drug: Entecavir combined with Tenofovir Amibufenamide
Entecavir group will receive entecavir orally once a day, 0.5mg each time, and fasting for 2h before and after taking the medicine
Also known as: Boludine/Rui fu en
Entecavir combined with Tenofovir Amibufenamide group will be treated with entecavir and tenofovir amibufenamide. Entecavir is administered in the same way as before. enofovir amibufenamide orally 25mg once a day with meals
Also known as: Heng mu
The inhibition rate of HBV-DNA between two groups
compare the inhibition rate of HBV-DNA between two groups at 96 weeks
Time frame: 96 weeks
The decrease of HBV DNA in the at 48 weeks between the two groups
comparing the decrease of HBV DNA in the at 48 weeks between the two groups
Time frame: 48 weeks
The HBeAg seroconversion rates at 48 weeks and 96 weeks
comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups
Time frame: 48 weeks and 96 weeks
The changes of HBsAg
The changes of HBsAg at 48 weeks and 96 weeks were compared between the two groups
Time frame: 48 weeks and 96 weeks
adverse side effects
comparing adverse side effects between the two groups
Time frame: 4、12、24、48、72 and 96 weeks
Plan to share: No
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Entecavir