Trials / Enrolling By Invitation
Enrolling By InvitationNCT06777173
Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for CHB in Adults
Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for Chronic Hepatitis B in Adults
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Beijing Ditan Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Establish a study cohort of adult chronic hepatitis B antiviral treatment based on the principle of responseguidedtreatment (RGT) corresponding to the child cohort, analyze the clinical cure factors of IC and IT stage adults chronic hepatitis B, and optimize the antiviral treatment plan. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
Detailed description
This research group established an adult randomized controlled study cohort corresponding to the children cohort: 1 immunetolerance (IT) and 1 immuneclearance (IC) antiviral treatment cohort, respectively according to 1: 1 Randomly divided into two intervention groups: nucleoside (acid) analogues (NAs) and NAs combined with pegylated interferon α-2b (PegIFNα-2b). 1 NAs treatment-advantaged population antiviral combined with novel immunotherapy cohort: PD-1 antibody, PegIFNα-2b and combination group were randomly enrolled 1:1:1, and the response guidance treatment plan was adjusted according to the response of patients during treatment, the HBsAg clearance rate at 24 weeks and 48 weeks of different optimal treatment groups was evaluated, the clinical curative characteristics and differences between children and adults were compared, and the key factors affecting clinical cure were screened. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peg interferon alfa-2b | NA combined with Peg interferon alfa-2b |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2025-01-15
- Last updated
- 2025-01-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06777173. Inclusion in this directory is not an endorsement.