Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194480
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-12
Brief Title:
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
Status:
COMPLETED
Status Verified Date:
2008-10
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:
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus HCV infections The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users IDUs with acute HCV
Detailed Description:
IDUs are at high risk for developing HCV Pegylated interferon is a man-made form of interferon a chemical naturally produced by the body that works to fight viruses Interferon helps to stop HCV from replicating and helps the immune system to kill HCV The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV
This trial will last 24 weeks Participants will be randomly assigned to one of two groups Group 1 will receive pegylated interferon while group 2 will receive an active control Injection with either pegylated interferon or control will occur weekly During each injection visit participants will be asked about adverse events including common side effects to interferon such as injection site reactions headache myalgias arthralgias insomnia and hair loss At Weeks 2 4 and then every 4 weeks thereafter participants will complete depression self-reports Laboratory assessments will occur at Week 2 and then on a monthly basis for the remainder of the study Follow-up assessments will occur every 4 weeks after Week 24
This trial will last 24 weeks Participants will be randomly assigned to one of two groups Group 1 will receive pegylated interferon while group 2 will receive an active control Injection with either pegylated interferon or control will occur weekly During each injection visit participants will be asked about adverse events including common side effects to interferon such as injection site reactions headache myalgias arthralgias insomnia and hair loss At Weeks 2 4 and then every 4 weeks thereafter participants will complete depression self-reports Laboratory assessments will occur at Week 2 and then on a monthly basis for the remainder of the study Follow-up assessments will occur every 4 weeks after Week 24
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 |
|---|---|---|---|
| R21DA016066-01 | NIH | None | httpsreporternihgovquickSearchR21DA016066-01 |