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PD-1 Inhibitor

Cemiplimab for Hepatitis B

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing cemiplimab, a medicine that boosts the immune system, in patients with hepatitis B who are already on antiviral therapy. The goal is to see if it can help their bodies fight the virus more effectively. Cemiplimab is being studied for its potential to enhance immune response in patients with various conditions, including cutaneous squamous cell carcinoma.

Eligible Conditions
  • Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90
This trial's timeline: 3 weeks for screening, Varies for treatment, and entry and weeks 6, 8, 12, 14, 18, 24, 36, 54, 72,90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Number of participants who experienced any targeted safety event that is related to study treatment
Number of participants with any AE
Secondary study objectives
Change in quantitative HBeAg from pre-treatment
Change in quantitative HBsAg from pre-treatment
Detection of hepatitis B core-related antigen (HBcrAg)
+3 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
Pyrexia
13%
Subcutaneous abscess
13%
Diarrhoea
13%
Hyperthyroidism
13%
Nausea
13%
Constipation
13%
Infusion related reaction
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy to Cemiplimab*
Cemiplimab
Chemotherapy*

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: Cemiplimab (3 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Group II: Cohort 2: Cemiplimab (1 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 1 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Group III: Cohort 1: Cemiplimab (0.3 mg/kg)Experimental Treatment1 Intervention
Participants will receive cemiplimab 0.3 mg/kg dosed in two infusions, one infusion at Week 6 and Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,320 Previous Clinical Trials
5,364,645 Total Patients Enrolled
17 Trials studying Hepatitis B
9,831 Patients Enrolled for Hepatitis B
Regeneron PharmaceuticalsIndustry Sponsor
667 Previous Clinical Trials
386,013 Total Patients Enrolled
Debika Bhattacharya, MDStudy ChairUCLA CARE Center CRS
~0 spots leftby Sep 2027
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