Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241618
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2005-10-18
Brief Title:
Timing and Duration of Acute Hepatitis C Treatment
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Phase IV Study of Treatment of Acute Hepatitis C With Pegylated Interferon
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of cases persist and become chronic This randomized trial assesses the efficacy and safety of peginterferon alfa-2b The investigators hypothesize that therapy strategies could prevent the development of chronic hepatitis
Detailed Description:
With nearly 4 million people in the United States and an estimated 170-200 million people worldwide the hepatitis C virus HCV represents a clear and significant public health issue Unfortunately for most people infected with HCV 70-85 spontaneous resolution is uncommon and 60 to 80 of patients with acute hepatitis C infection develop chronic hepatitis This randomized trial focuses on defining the effect of treatment of acute HCV on prevention of chronic hepatitis in addition to optimization of the treatment regimen onset and the length of peginterferon alpha therapy in acute hepatitis C infections This randomized multi-center prospective study assesses the efficacy of peginterferon in acute hepatitis We will also compare differences in sustained viral response rates in patients with acute hepatitis C starting treatment at 8 12 or 24 weeks We will also compare the efficacy of 8 12 or 24 weeks therapy with PEG-IFN-alpha All eligible patients are enrolled and screened for an initial observation period starting from the time of their first positive HCV-RNA-PCR during which bi-weekly serum ALT and HCV-RNA subjects were performed Patients who did not resolve spontaneously loss of HCV-RNA without treatment by the end of the observation period were randomly assigned to receive PEG-IFN-alpha at the assigned onset andor duration Patients who do not consent to therapy at enrollment are included as a non-randomized comparison group All subjects with SVR were followed for 48 weeks after the follow-up at 24 weeks when SVR was determined
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 |
|---|---|---|---|
| ISID | None | None | None |
| AI054887 | None | None | None |
| AI41563 | None | None | None |
| Fulbright | None | None | None |
| TEMPUS | None | None | None |