Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363155
Status:
COMPLETED
Last Update Posted:
2006-08-15
First Post:
2006-08-10
Brief Title:
KRN7000 in Chronic Hepatitis B
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Phase III Trial of KRN7000 in Patients With Chronic Hepatitis B Infection
Status:
COMPLETED
Status Verified Date:
2006-08
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 purpose of this trial is to determine the safety tolerability and effectiveness of KRN7000 for chronic hepatitis B infection
Detailed Description:
KRN7000 is reported to inhibit HBV replication in HBV transgenic mice Anti-viral effects of KRN7000 can be expected in HBV as the compound is able to induce not only IFN-alphabeta but also IFN-gamma and TNF-alpha In two clinical trials KRN7000 was safe in both healthy volunteers and solid cancer patients particularly the compound has not been reported to show drug-related serious adverse events A phase III trial is of significance in assessing the safety and efficacy of KRN7000 treatment for CHB patients
The 300 microgramm2 dose level comparable to 10 microgramkg can be considered as the highest safe dose level for the phase III trial for CHB patients with 3 dose levels Dose incrementation will be performed in a logarithmic manner 01 1 and 10 microgramkg
In the phase I trial for solid tumor patients weekly administration of KRN7000 did not allow sufficient time for NKT cell recovery As KRN7000 is reported to be an activating ligand for NKT cells it is logical to assume that a dosing interval that provides time for recovery of NKT cells is optimal In fact cytokine production after repeating dosing when NKT cells were hardly detected in the peripheral blood was not observed As it took approximately 4 weeks for NKT cells to recover to pre-dose levels after a single administration monthly administration is now proposed for this trial
The 300 microgramm2 dose level comparable to 10 microgramkg can be considered as the highest safe dose level for the phase III trial for CHB patients with 3 dose levels Dose incrementation will be performed in a logarithmic manner 01 1 and 10 microgramkg
In the phase I trial for solid tumor patients weekly administration of KRN7000 did not allow sufficient time for NKT cell recovery As KRN7000 is reported to be an activating ligand for NKT cells it is logical to assume that a dosing interval that provides time for recovery of NKT cells is optimal In fact cytokine production after repeating dosing when NKT cells were hardly detected in the peripheral blood was not observed As it took approximately 4 weeks for NKT cells to recover to pre-dose levels after a single administration monthly administration is now proposed for this trial
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