NCT06544551

Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
DRUG	Peginterferon Alfacon-2	Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.
DRUG	Peginterferon Alfacon-2 placebo	Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

Timeline

• Start date: 2021-12-28
• Primary completion: 2023-11-30
• Completion: 2023-12-30
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

34 sites across 1 country: China