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Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy

NCT04046107 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunotherapeutic activity of cemiplimab in participants with hepatitis B virus (HBV) on suppressive antiviral therapy.

Conditions

  • Hepatitis B Virus

Interventions

BIOLOGICAL

Cemiplimab

Administered as an intravenous (IV) infusion

Sponsors & Collaborators

Principal Investigators

  • Debika Bhattacharya, MD · UCLA CARE Center CRS

  • Jordan Feld, MD, PhD · University Health Network / Toronto Centre for Liver Disease

  • Raymond T. Chung, MD · Massachusetts General Hospital CRS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046107 on ClinicalTrials.gov