Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients (NCT04864366) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients
China150 participantsStarted 2021-04-30
Plain-language summary
The objective of this clinical study was to observe the changes of HBsAg levels after a sequential 48 weeks-treatment of TAF in ETV experienced CHB patients and to monitor the levels of cytokines such as IFN-λ3, IP-10, IL-12, IL-10, and IL-21.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
common criteria:
* Age 18-70 years old (including both ends), male or female, chronic HBV infection (HBsAg positive for more than 6 months, or liver biopsy results show chronic hepatitis B infection)
* HBsAg positive
* Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent.
* Lifestyle requirements:
All subjects considered by the investigator to be sexually active and capable of becoming pregnant or making sexual partner become pregnant must agree to use an effective contraceptive method for the entire study period (from the signing of the informed consent to at least 28 days after the last dose of the investigational drug was administered).
Addition criteria:
Treatment naive patients
* HBV DNA\> 2×104 IU/ml
* ALT\>2×ULN；or ALT\>1×ULN，but liver biopsy showed inflammation greater than or equal to G2, or/and liver fibrosis greater than or equal to S2
* No treatment with NA or/or αIFN within 1 year
ETV treatment experienced patients
* ETV treatment for 1 to 2 years before
* HBsAg\>3000IU/mL
* HBV DNA\<20IU/mL
* ALT\<1×ULN
* No other NA therapy prior to entecavir treatment
* Patients had a desire to convert to TAF therapy
Exclusion Criteria:
Treatment naive patients
* treated with NA or/or αIFN within 1 year
* Pregnant women, lactating women, or women who plan to become pregnant within 2 years
* Co-infection with Hepatitis C, Hepatitis D or HIV;
* Chronic liver disea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of serum HBsAg at week 48 from baseline.
Timeframe: from baseline to week 48 after TAF treatment