Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
- Conditions
- Chronic Hepatitis B
- Interventions
- Biological: PEG IFN α-2b; TAF
- Registration Number
- NCT05490836
- Lead Sponsor
- Huashan Hospital
- Brief Summary
The study is aimed to explore the safety and efficacy of the pulse usage , comparing to continuous usage, of Peginterferon alfa-2b Injection (PEG IFN α-2b) Combined With tenofovir alafenamide (TAF) in treatment of naive chronic hepatitis B patients with HBeAg negative.
- Detailed Description
Using antiviral drugs with different mechanisms of action is one of the effective means to improve the therapeutic outcome at present. At the same time, PEG-IFN is currently recognized as the only drug that can improve the functional cure rate of chronic hepatitis B, and PEG-IFN clinical application is limited due to adverse reactions. Exploring ways to reduce adverse reactions of PEG-IFN and improve PEG-IFN curative effects is the hot spot topic but also difficult at present.
Previously clinical practice have found that the temporary withdrawal of interferon have little influences on the whole clinical outcome in patients withdrawal of interferon due to adverse reactions, and there is indeed a continuous effect after the withdrawal of PEG-IFN for a certain period of time. Therefore, it is conceive that pulse usage of PEG-IFN (eg. use for 8 weeks followed by 4 weeks off) may be a effective method to reduce PEG-IFN adverse reactions while ensuring efficacy.
By comparing the safety and efficacy of pulsed and continuous combination therapy of Peg-IFNα-2b with TAF and in treatment naive HBeAg-negative CHB patients, the investigators hope to develop a better treatment plan for chronic hepatitis B.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description continuous treatment arm PEG IFN α-2b; TAF - pulse treatment arm PEG IFN α-2b; TAF -
- Primary Outcome Measures
Name Time Method The rate of HBsAg negative week 48
- Secondary Outcome Measures
Name Time Method change in HBsAg level from baseline week 48 The Rate of HBsAg seroconversion week 48 Proportion of patients with HBV DNA Below the detection limit week 24 and week 48 Number of patients with treatment-related adverse events from baseline to week 48