Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300807
Status:
UNKNOWN
Last Update Posted:
2007-03-07
First Post:
2006-03-07
Brief Title:
Study of XTL6865 in Patients With Chronic Hepatitis C Virus Infection
Sponsor:
XTL Biopharmaceuticals
Organization:
XTL Biopharmaceuticals
Study Overview
Official Title:
A Phase I Randomized Double Blind Placebo-Controlled Multi-Center Study of the Safety and Virologic Effects of Ascending Single and Multiple Doses of XTL6865 in Patients With Chronic Hepatitis C Virus Infection
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
1 Evaluate the safety tolerability and virologic activity of escalating single and multiple doses of XTL6865 a mixture 11 of two human monoclonal antibodies HCV-AbXTL68 and HCV-AbXTL65 in patients with chronic hepatitis C virus infection
2 Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection
2 Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection
Detailed Description:
The purpose of this study is to evaluate the safety tolerability and virologic activity of escalating single and multiple doses of XTL6865 a mixture 11 of two human monoclonal antibodies HCV-AbXTL68 and HCV-AbXTL65 in patients with chronic hepatitis C virus infection
An additional purpose of this study is to assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection
This study is a randomized double blind placebo-controlled multi-center design of ascending single doses in patients with chronic hepatitis C virus HCV infection In addition to Placebo the following XTL6865 doses will be administered 5 mg 20 mg 75 mg 250 mg 600 mg 1200 mg and 2400 mg No patient will be enrolled in more than one dose level At each dose level 3 patients will receive XTL6865 and 1 patient will receive the Placebo After the single dose infusion the patients will be followed for 6 weeks
If certain criteria are met and the safety review of the 1200 mg dose cohort data determines that XTL6865 was safely administered and tolerated at that dose level the patients in the 600 mg and 1200 mg dose levels are eligible for the multiple dosing phase Infusions of 600 mgs will be given to 4 eligible patients one infusion per day for 5 days One patient will receive Placebo and 3 patients will receive XTL6865 600 mg The patients will be followed for 6 additional weeks
If certain criteria are not met the 2400 mg dose cohort will be infused After the safety review has determined that XTL6865 was safely administered and tolerated the patients in the 1200 mg and 2400 mg dose levels are eligible for the multiple dosing phase Infusions of 1200 mgs will be given to 4 eligible patients one infusion per day for 5 days One patients will receive Placebo and 3 patients will receive XTL6865 1200 mg The patients will be followed for 6 additional weeks
An additional purpose of this study is to assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection
This study is a randomized double blind placebo-controlled multi-center design of ascending single doses in patients with chronic hepatitis C virus HCV infection In addition to Placebo the following XTL6865 doses will be administered 5 mg 20 mg 75 mg 250 mg 600 mg 1200 mg and 2400 mg No patient will be enrolled in more than one dose level At each dose level 3 patients will receive XTL6865 and 1 patient will receive the Placebo After the single dose infusion the patients will be followed for 6 weeks
If certain criteria are met and the safety review of the 1200 mg dose cohort data determines that XTL6865 was safely administered and tolerated at that dose level the patients in the 600 mg and 1200 mg dose levels are eligible for the multiple dosing phase Infusions of 600 mgs will be given to 4 eligible patients one infusion per day for 5 days One patient will receive Placebo and 3 patients will receive XTL6865 600 mg The patients will be followed for 6 additional weeks
If certain criteria are not met the 2400 mg dose cohort will be infused After the safety review has determined that XTL6865 was safely administered and tolerated the patients in the 1200 mg and 2400 mg dose levels are eligible for the multiple dosing phase Infusions of 1200 mgs will be given to 4 eligible patients one infusion per day for 5 days One patients will receive Placebo and 3 patients will receive XTL6865 1200 mg The patients will be followed for 6 additional weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| XTL6865 | None | None | None |