NCT04640129

HBsAg Seroclearance in Adults With HBV Related Liver Fibrosis After Receiving Combined Therapy of Peg-IFN and Tenofovir.

A Multicentre Clinical Trial in HBsAg Seroclearance After Receiving Combined Therapy of Peginterferon and Tenofovir in Nucleos(t)Ide Analogue-treated Patients With HBV Related Liver Fibrosis.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Liver fibrosis caused by hepatitis B virus (HBV) infection is easy to progress to liver cirrhosis and liver cancer, with great harm and poor therapeutic effect. Nucleos(t)ide analogues (NAs) are the most commonly anti-HBV drugs currently . Long-term use of NAs can inhibit HBV DNA and achieve the purpose of reducing poor prognosis. However, adverse prognosis, such as liver cirrhosis and liver cancer, cannot be completely eliminated even under the status of virologic inhibition under THE action of NAs. Current studies have shown that the lower the HBV surface antigen (HBsAg) is, the better the long-term prognosis is. As another anti-HBV drug, pegylated-interferon-α (peg-IFN-α) has the immune regulation effect that NAs do not have, which can bring irreplaceable effects in HBsAg reduction and liver fibrosis reversal. Therefore, the combined therapy of NAs and peg-IFN-α is a hot issue in the field of liver diseases over the world, but the research and application of the combined therapy in patients with liver fibrosis are very few. The preliminary results of our previous research showed that the combined therapy of peg-IFN-α and NAs in patients with HBV related fibrosis were safe, and had a significant effect on HBsAg decline. On this basis, this study intends to carry out a multicentre, non-randomized concurrent controlled trial, comparing the safety and efficacy between combined therapy (peg-IFN-α plus tenofovir) and tenofovir monotherapy in patients with liver fibrosis, especially focusing on HBsAg's decline and clearance, and the improvement of liver fibrosis degree, in order to find a better therapy, and to guide the clinical decision making.

Conditions

• Liver Fibrosis

Interventions

Type	Name	Description
DRUG	PEG-Interferon Alfa, Tenofovir Disoproxil Fumarate	Combination therapy group was treated with PEG-interferon Alfa in addition to TDF monotherapy
DRUG	Tenofovir Disoproxil Fumarate	TDF monotherapy

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2020-11-23
• Last updated: 2024-01-26

Locations

1 site across 1 country: China