Your session is about to expire
← Back to Search
Monoclonal Antibodies
HepB mAb19 for Chronic Hepatitis B
Phase 1
Recruiting
Led By Marina Caskey, MD
Research Sponsored by Rockefeller University
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 48 weeks
Awards & highlights
Study Summary
This trial tests the safety & effectiveness of a new antibody-based drug to treat chronic hepatitis B in people already on medication.
Who is the study for?
Adults aged 18-70 with chronic Hepatitis B on nucleos(t)ide therapy for at least 6 months can join. They must not be pregnant, agree to use contraception, and have a stable viral load. Excluded are those with severe allergies, heart disease, recent acute infections, advanced liver fibrosis or cancerous liver lesions.Check my eligibility
What is being tested?
The trial is testing HepB mAb19, an experimental antibody targeting the hepatitis B virus in patients already on standard treatment. It's compared against a placebo (sterile saline). The study will look at safety and how well it works to control the virus.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to the monoclonal antibody such as skin rashes or more serious conditions like anaphylaxis. Since this is a first-in-human study, close monitoring for any unexpected side effects is critical.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the curve (AUC) of HepB mAb19
Changes in ALT within 2,12, 24 and 48 weeks after administration
Changes in AST within 2,12, 24 and 48 weeks after administration.
+11 moreSecondary outcome measures
Change in quantitative HBsAg levels from baseline (day 0) at each scheduled follow up visit.
Detection of HBsAg by a qualitative assay at each scheduled follow up visit.
Rate and severity of treatment-related adverse events during study follow up.
+1 moreTrial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 5: Maximum tolerated dose, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at the MTD
Group II: Group 4a: HepB mAb19 30 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 30 mg/kg.
Group III: Group 3a: HepB mAb19 10 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 10 mg/kg.
Group IV: Group 2a: HepB mAb19 3 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 3 mg/kg.
Group V: Group 1a: HepB mAb19 1 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 1 mg/kg.
Group VI: Group 2b: Placebo 3 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 3 mg/kg.
Group VII: Group 1b: Placebo 1 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 1 mg/kg.
Group VIII: Group 4b: Placebo 30 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 30 mg/kg.
Group IX: Group 3b: Placebo 10 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 10 mg/kg.
Find a Location
Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,320 Total Patients Enrolled
2 Trials studying Hepatitis B
22 Patients Enrolled for Hepatitis B
NYU Langone HealthOTHER
1,369 Previous Clinical Trials
840,561 Total Patients Enrolled
1 Trials studying Hepatitis B
200 Patients Enrolled for Hepatitis B
Marina Caskey, MDPrincipal InvestigatorThe Rockefeller University
15 Previous Clinical Trials
714 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on stable hepatitis B treatment for at least 6 months.I am between 18 and 70 years old.I haven't taken steroids, immunosuppressants, or certain cancer drugs in the last 6 months.My partner is sterile, confirmed by tests, and is my only partner.I have not had a serious infection or significant illness in the last 2 weeks.I have signs of severe liver scarring.I have a history of chronic liver, immune complex, or autoimmune diseases.I have been diagnosed with hepatitis B for 6 months or more.I have had a bone marrow or organ transplant.I have a history of heart disease.I have received anti-HBV medication before.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2b: Placebo 3 mg/kg, IV
- Group 2: Group 5: Maximum tolerated dose, IV
- Group 3: Group 4a: HepB mAb19 30 mg/kg, IV
- Group 4: Group 2a: HepB mAb19 3 mg/kg, IV
- Group 5: Group 1b: Placebo 1 mg/kg, IV
- Group 6: Group 1a: HepB mAb19 1 mg/kg, IV
- Group 7: Group 4b: Placebo 30 mg/kg, IV
- Group 8: Group 3a: HepB mAb19 10 mg/kg, IV
- Group 9: Group 3b: Placebo 10 mg/kg, IV
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the potential risk associated with Group 5: Maximum tolerated dose, IV for individuals?
"Limited evidence exists to support the safety and efficiency of Group 5: Maximum tolerated dose, IV. As such, it received a score of 1 on our scale from 1 to 3."
Answered by AI
Is the recruitment of individuals over 35 years old part of this research project?
"To be eligible for this investigation, the participant must lie between 18 and 70 years of age. In addition to this study, there are 24 separate studies available exclusively to patients under 18 and 220 specifically tailored towards those over 65."
Answered by AI
Who qualifies as an eligible participant in this trial?
"The selection criteria for this trial calls for 37 participants who are between 18-70 years old and have hepatitis b."
Answered by AI
What is the primary aim of this research endeavor?
"The primary purpose of this clinical trial, to be evaluated within a 14-day window, is to ascertain and quantify the severity of Grade 2 or higher unsolicited adverse events post-treatment. Additionally, researchers will measure anti-HepB mAb19 antibodies at baseline and after IP administration; assess serum HBsAg levels from day 0 till end of study follow up; as well as detect qualitative presence of HBsAg until completion of study."
Answered by AI
Are researchers currently recruiting participants for this research endeavor?
"The clinicaltrials.gov registry reveals that this medical study, which was published on June 1st of 2023, is no longer actively recruiting patients. However, there exist 268 other trials open for enrollment at the present moment in time."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Been on medication. However I want to be involved in any endeavors that'll lead to curative solutions and possibly
the wiping out of HBV in the face of the world.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger