NCT06323681

Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）

A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B （Leading Study）

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,016 (estimated)
• Sponsor: Qing XIe · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy. This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Peginterferon α-2b based treatment group	Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended.
DRUG	NAs monotherapy group	First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks.

Timeline

• Start date: 2024-02-04
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: China