NCT05490836

Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients

Peginterferon Alfa-2b Combined With Tenofovir Alafenamide Improves the Functional Cure Rate in Patients With HBeAg Negative Chronic Hepatitis B: an Open-labeled, Multicenter, Randomized and Controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	PEG IFN α-2b; TAF	TAF was orally administered once a day, and PEG IFN α-2b was subcutaneously injected 135 μg or 180μg once a week. treatment continuous for 48 weeks.
BIOLOGICAL	PEG IFN α-2b; TAF	TAF was orally administered once a day, and PEG IFN α-2b was subcutaneously injected 135 μg or 180μg once a week for 8 weeks and followed by 4 weeks off. treatment continuous for 48 weeks.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-01
• Completion: 2024-12-01
• First posted: 2022-08-08
• Last updated: 2022-08-08