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

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04046107
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Hepatitis B Virus

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — BIOLOGICAL
    Administered as an intravenous (IV) infusion

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Aug 2023
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Cemiplimab (0.3 mg/kg)
    Participants will receive cemiplimab 0.3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
  • Experimental: Cohort 2: Cemiplimab (1 mg/kg)
    Participants will receive cemiplimab 1 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
  • Experimental: Cohort 3: Cemiplimab (3 mg/kg)
    Participants will receive cemiplimab 3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.

Primary Outcome Measure

Number of participants who experienced any targeted safety event that is related to study treatment [ Time Frame: From Week 6 to Week 18 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Ucsf Hiv/Aids CrsSan FranciscoCalifornia94110-
The Ponce de Leon Center CRSAtlantaGeorgia30308-2012-
Massachusetts General Hospital CRS (MGH CRS)BostonMassachusetts02114-

Find similar trials in San Francisco, CA

By research site
Ucsf Hiv/Aids Crs· San Francisco, CAThe Ponce de Leon Center CRS· Atlanta, GAMassachusetts General Hospital CRS (MGH CRS)· Boston, MA

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