Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115908
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2005-06-26
Brief Title:
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
Sponsor:
Human Genome Sciences Inc
Organization:
Human Genome Sciences Inc
Study Overview
Official Title:
A Phase 2b Randomized Multi-Center Active-Controlled Open-Label Study to Evaluate the Efficacy and Safety of Albuferon Recombinant Human Albumin-Interferon Alfa Fusion Protein in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
Status:
COMPLETED
Status Verified Date:
2013-11
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 the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon IFN alfa treatment-naïve subjects with chronic hepatitis C genotype 1 The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group peginterferon alfa-2a PEGASYS PEG-IFNalfa-2a All subjects will also receive oral daily ribavirin
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