Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120835
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2005-07-11
Brief Title:
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Open-Label Multiple-Dose Study to Evaluate the Safety Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2010-06
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:
None
Brief Summary:
This study is being conducted in treatment-naive patients no previous hepatitis C treatment to evaluate the safety of valopicitabine NM283 alone and together with pegylated interferon a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon
Detailed Description:
None
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