Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649266
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Trial to Evaluate the Efficacy Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
Sponsor:
None
Organization:
None
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:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 n10 and a deferred active group n5 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 ie they will know which treatment the participants receive at all times
There will be 2 treatment groups - an active group n10 and a deferred active group n5 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 ie they will know which treatment the participants receive at all times
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None