Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372983
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2006-09-05
Brief Title:
Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
Sponsor:
Cellectar Biosciences Inc
Organization:
Cellectar Biosciences Inc
Study Overview
Official Title:
A Randomized Placebo Controlled Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of NOV-205 in Chronic Viral Hepatitis C Subjects Genotype 1 Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
Status:
COMPLETED
Status Verified Date:
2007-12
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 research trial is to find out whether NOV-205 is well tolerated compared to placebo salt water in people with hepatitis C In addition this trial will test how NOV-205 is absorbed by your body after single and multiple doses of the trial drug and it will look for early signs of therapeutic activity decreases in indicators in the blood for the hepatitis C virus and for liver damage This is known as pharmacokinetics PK NOV-205 is an experimental drug Experimental means that the trial drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration FDA However NOV-205 has been approved by the Russian Federation for treatment of liver diseases including hepatitis C Clinical studies in that country showed that subjects treated with NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver damage
Detailed Description:
This Phase 1b trial aims to evaluate the pharmacokinetic profile of NOV-205 and in comparison to placebo identify early signs of antiviral activity with a quantitative reduction of 05 log10 in serum HCV RNA level Elbeik 2004 and establish a safety profile of NOV-205 as monotherapy in subjects with chronic HCV who are non-responders to treatment with pegylated interferon plus ribavirin This trial will also explore the effect of NOV-205 on serum biochemical markers of liver damage eg alanine aminotransferase ALT as indications of biologic activity Results of this trial will guide the design of future Phase 2 studies of NOV-205 in chronic hepatitis C subjects
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