Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248339
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2005-11-02
Brief Title:
Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
An Open-label Randomized Pilot Study to Compare the Effectiveness of Peginterferon-alfa-2b Plus Ribavirin to Peginterferon-alfa-2b Plus Epoetin-alfa and Two Doses of Ribavirin in the Treatment of Chronic Hepatitis C Virus Infection
Status:
COMPLETED
Status Verified Date:
2017-03
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 study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavirin thus increasing chances at lower viral levels and raising sustained virologic response
Detailed Description:
Chronic infection with hepatitis C virus HCV leads to cirrhosis hepatocellular carcinoma and liver failure The treatment for end stage liver disease is hepatic transplantation It is therefore important the patients with chronic HCV infection be recognized and treated before they develop advanced disease The most effective therapy for patients with chronic HCV appears to be the combination of peginterferon-alpha-2b PEG-Intron plus ribavirin Overall 54 of patients treated with these medications achieve sustained virologic response Response to therapy is greatly enhanced in those patients who can tolerate this therapy and remain on treatment without the need for dose reduction The single most common reason for reducing the dose of ribavirin is anemia Ribavirin causes a dose dependent hemolytic anemia and this side effect is believed to be exacerbated by the marrow suppressive effects of interferon Preliminary studies have suggested that anemia can be overcome with the use of erythropoetin The present pilot study will test the hypothesis that treatment with Epoetin-alph will allow patients with chronic HCV to utilize higher doses of ribavirin along with PEG-Intron therapy and that this will lead to a more rapid decline in HCV RNA titer and an increase in sustained virologic response
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