Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505928
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Parallel-group Randomized Open-label Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
L47-HD-MN
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 111 ratio The subjects will receive continuous L47 21 mgd and 42 mgd sc treatment for 48 weeks groups A and B or delayed treatment for 48 weeks group C Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment
Detailed Description:
This is a three-arm parallel-group randomized open-label delayed-controlled phase IIb clinical trial Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into the 21 mg group 42 mg group and delayed-treatment group at a 111 ratio The subjects will receive continuous L47 21 mgd and 42 mgd sc treatment for 48 weeks or delayed treatment for 48 weeks group C The interim analysis will be performed after the subjects complete the 24-week treatment Primary endpoint evaluation will be performed after the subjects complete the 48-week treatmentAfter the primary endpoint evaluation each group will enter the 96-week extended treatment period Groups A and B will continue to receive L47 treatment at the original doses Group C will initiate L47 treatment 42 mgday sc Table 12 After the subjects have completed the extended treatment each group will undergo off-treatment observation for 96 weeksThroughout the study subjects will be closely monitored and evaluated for safety including adverse events AEs
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