Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352235
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
2006-07-13
Brief Title:
Phase III Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Phase III Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Status:
COMPLETED
Status Verified Date:
2006-07
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:
Phase III trial of KRN7000 in patients with chronic hepatitis C
Study objectives To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer
The primary efficacy parameter HCV-RNA response at the end of treatment Secondary efficacy parameter Serum ALT response Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells
Number of dose levels 3 Investigational product KRN7000 Route of administration intravenous Dosages and frequency 01 1 10 mcgkg monthly injection 3 times day 0 day 28 and day 56
Study objectives To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer
The primary efficacy parameter HCV-RNA response at the end of treatment Secondary efficacy parameter Serum ALT response Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells
Number of dose levels 3 Investigational product KRN7000 Route of administration intravenous Dosages and frequency 01 1 10 mcgkg monthly injection 3 times day 0 day 28 and day 56
Detailed Description:
Phase III trial of KRN7000 in patients with chronic hepatitis C
This study is a multicenter double-blind randomized placebo-controlled phase III dose-escalation trial The protocol is conducted in The Netherlands Belgium and Germany Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer KRN7000 2S 3S 4R-1-O-a-D-galactopyranosyl-N-hexacosanoyl-2-amino-134-octadecanetriol Kirin Pharmaceutical Co Ltd Gunma Japan or placebo intravenously thrice with intervals of 4 weeks Cohorts of 12 patients are entered at each of the three dose levels 01 1 and 10 mgkg body weight Three patients per dose level are randomized to the placebo arm
Dose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort After completion of 8 weeks of treatment with injections at 0 4 and 8 weeks patients are monitored without further therapy for an additional 16 weeks
Study objectives The objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer The primary efficacy parameter is the response at the end of treatment based on serum hepatitis C virus ribonucleic acid HCV RNA levels As a secondary efficacy parameter serum ALT levels are evaluated Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells
This study is a multicenter double-blind randomized placebo-controlled phase III dose-escalation trial The protocol is conducted in The Netherlands Belgium and Germany Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive a-GalCer KRN7000 2S 3S 4R-1-O-a-D-galactopyranosyl-N-hexacosanoyl-2-amino-134-octadecanetriol Kirin Pharmaceutical Co Ltd Gunma Japan or placebo intravenously thrice with intervals of 4 weeks Cohorts of 12 patients are entered at each of the three dose levels 01 1 and 10 mgkg body weight Three patients per dose level are randomized to the placebo arm
Dose escalation to the next cohort are decided after evaluation by a safety review board of all the safety data collected on all the patients who had completed 3 weeks after the first injection in the preceding dose cohort After completion of 8 weeks of treatment with injections at 0 4 and 8 weeks patients are monitored without further therapy for an additional 16 weeks
Study objectives The objective of the study is to evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer The primary efficacy parameter is the response at the end of treatment based on serum hepatitis C virus ribonucleic acid HCV RNA levels As a secondary efficacy parameter serum ALT levels are evaluated Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells
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