NCT03575208

Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B

Withdrawn Phase 2 Last updated 6 April 2022

What this trial tests

Phase 2 trial testing hepatitis B immune globulin (HBIg) in Chronic Hepatitis B. Withdrawn.

Timeline

13 February 2019

Primary endpoint
29 March 2022

29 March 2022

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	13 February 2019
Primary completion	29 March 2022
Estimated completion	29 March 2022
Sites	1 location across United States

Drugs / interventions tested

• hepatitis B immune globulin (HBIg) — full drug profile →
• Pegylated interferon alfa (pegIFN) — full drug profile →

Conditions studied

• Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

18 and older, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. HBV Vaccines: Advances and Development.
   Mahmood F, Xu R, Awan MUN, Song Y, et al · · 2023 · cited 42× · PMID 38140265 · DOI 10.3390/vaccines11121862
2. Strategy, Progress, and Challenges of Drug Repurposing for Efficient Antiviral Discovery.
   Li X, Peng T. · · 2021 · cited 25× · PMID 34017257 · DOI 10.3389/fphar.2021.660710
3. Is PD-1 blockade a potential therapy for HBV?
   Féray C, López-Labrador FX. · · 2019 · cited 18× · PMID 32040093 · DOI 10.1016/j.jhepr.2019.07.007
4. Recent advances in polymeric nanoparticles for the treatment of hepatic diseases.
   Gao F, Feng X, Li X. · · 2025 · cited 11× · PMID 39925843 · DOI 10.3389/fphar.2025.1528752