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Immunoglobulin

hepatitis B immune globulin (HBIg) for Chronic Hepatitis B

Phase 2
Waitlist Available
Led By Marc G Ghany, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 week 84
Awards & highlights

Summary

Background: Hepatitis B is a viral infection of the liver. When the immune system tries to clear hepatitis B, it damages the liver. Eventually, the immune system gets exhausted fighting the virus. Researchers want to see if giving large doses of an antibody (HBIg) with the drug peginterferon will boost the immune system in people with this disease. Objectives: To observe the effect of large doses of antibody against the hepatitis B surface antigen on the immune response to the virus. To see if removing hepatitis B surface antigen from the blood enhances the action of peginterferon. Eligibility: Adults ages 18 and older with hepatitis B Design: Participants will be screened twice with a medical history, physical exam, and blood and urine tests. Participants will be randomly put in one of two groups. All participants will get peginterferon for 24 weeks. One group will first get HBIg for 12 weeks. Participants in the combination group will have a 4-day clinic stay. They will have: Repeats of screening tests Eye exam Liver ultrasound The first dose of HBIg by IV over 2 hours These participants will get HBIg at the clinic up to 8 times over 12 weeks then start the peginterferon. All participants will get peginterferon for 24 weeks. They will get it by injection under the skin once a week. They may do this themselves. They will keep a drug diary. They will have 5 visits to assess response and monitoring for safety.. After stopping the study drug, participants will have 4 follow-up visits over 36 weeks. They will repeat screening tests and have 1 liver ultrasound.

Eligible Conditions
  • Chronic Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement of HBsAg-specific T cell responses HBIG only group
Improvement of HBsAg-specific T cell responses both groups
NK cell response to the first peginterferon injection both groups
Secondary outcome measures
Change in HBsAg from baseline to 24 weeks off peginterferon therapy
Change in HBsAg from baseline to 48 weeks off peginterferon therapy
HBsAg loss

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HBIG followed by Peginterferon alfa-2aExperimental Treatment2 Interventions
HBIg x 12 weeks followed by peginterferon alfa-2a 180mcg x 24 weeks
Group II: Peginterferon alfa-2aActive Control1 Intervention
Peginterferon alfa-2a 180mcg x 24 weeks

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,381 Previous Clinical Trials
4,315,102 Total Patients Enrolled
Marc G Ghany, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
1,481 Total Patients Enrolled
~0 spots leftby Sep 2025