Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT06649266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-09-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
Sponsor:
Ribocure Pharmaceuticals AB
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: