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Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with Both Chronic Hepatitis B and HIV

Clinical Trial Details

This study is evaluating the experimental drug selgantolimod (SLGN) for patients with Chronic Hepatitis B (CHB) to try to prevent progression and reverse disease. 

Experimental means that SLGN has not yet been approved by the U.S. Food and Drug Administration (FDA). 

This study will assess how safe and tolerated treatment is. It will also assess the amount of hepatitis B surface antigen (HBsAg) in a person's blood during and after 24 weeks of treatment. HBsAg is an important test that shows active infection with hepatitis B virus (HBV) and helps in the prediction of the clinical outcome and management of HBV without HIV.

This study will have two groups: those who will receive SLGN and those who will receive placebo. Participants will be randomized 3:1 to the active treatment arm. This means that there is a 75% chance of getting assigned to receive SLGN, and a 25% chance of receiving placebo. Participants will take the medication once weekly by mouth for 24 weeks.

This study intends to establish the safety profile, tolerability, and effect on amount of HBsAg in a participant’s blood when given over 24 weeks in persons living with Human Immunodeficiency Virus (HIV) and CHB. 

Key Eligibility: 
  1. Living with HIV & Hepatitis B 
  2. Between 18-70 years old 
  3. On HIV and Hepatitis B meds for over 5 years 
  4. Suppressed (very low) HIV and Hepatitis B viral loads 

Detailed eligibility will be reviewed when you contact the study team.

 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jonathan Berardi, NP
212-746-4177
jlb4002@med.cornell.edu

Chelsea - Manhattan

Chelsea Clinical Trial Location

Contact(s)

Jonathan Berardi, NP
212-746-4177
jlb4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2207025065

ClinicalTrials.gov:

NCT05551273

Sponsor:

A5394

Status

Open to Enrollment

Age Group

Adult

Sponsor