NCT06649266

Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D

A Phase 2a, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D Virus Infection, Including a Randomised, Single Blinded, Placebo-controlled Exploratory Part

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Ribocure Pharmaceuticals AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. The main questions it aims to answer are: Does drug RBD106 reduce the HDV RNA levels? What medical problems may participants experience when taking drug RBD1016? Researchers will compare drug RBD1016 to a placebo to see if drug RBD1016 works to treat chronic hepatitis D. Participants will: Receive drug RBD1016 or a placebo several times throughout the trial. Visit the clinic once every 4-6 weeks for checkups and tests.

Detailed description

This is a multicentre, randomised, partly blinded, placebo-controlled clinical trial to evaluate the efficacy, safety and pharmacokinetics (PK) of RBD1016 subcutaneous injections in participants with chronic HDV infection. First part of the trial: There will be 2 treatment groups - an active group (n=10) and a deferred active group (n=5), with participants allocated randomly. In the active group, participants will receive RBD1016. In the deferred active group, participants will receive 4 doses of placebo followed by deferred treatment with doses of RBD1016. Both groups will be on a stable nucleoside analogue (NA) treatment course during the trial . All participants will be blinded to the trial treatment for the 16 weeks after the first dose. Then, investigators and other clinic staff will be unblinded, i.e., they will know which treatment the participants receive at all times. Open-label extension part (site 01 only): continued IMP-treatment with additionally 3 doses of IMP administered 12 weeks apart. This part of the trial is conducted to collect long-term safety data and further exploratory efficacy measures. Only participants who may benefit from continued treatment in the ,trial, according to the judgement of the investigator, will be eligible for the open-label extension part of the trial.

Conditions

• Chronic Hepatitis D

Interventions

Type	Name	Description
DRUG	RBD1016	RBD1016, active drug.
DRUG	Placebo	Placebo that is identical in appearance and volume to the doses of active IMP.

Timeline

• Start date: 2024-08-21
• Primary completion: 2026-09-01
• Completion: 2027-08-01
• First posted: 2024-10-18
• Last updated: 2026-02-03

Locations

2 sites across 1 country: Sweden