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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

Study Summary

This trial will study if a new drug is safe and works to treat hepatitis B virus in people who are already taking antiviral therapy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Number of participants who experienced any targeted safety event that is related to study treatment
Number of participants with any AE
Secondary outcome measures
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%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy

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
~1340

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,132 Total Patients Enrolled
17 Trials studying Hepatitis B
9,831 Patients Enrolled for Hepatitis B
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,847 Total Patients Enrolled
Debika Bhattacharya, MDStudy ChairUCLA CARE Center CRS

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ucsf Hiv/Aids Crs
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy
2024. "Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046107.
~0 spots leftby Sep 2027
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