Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147784
Status:
COMPLETED
Last Update Posted:
2008-03-28
First Post:
2005-09-06
Brief Title:
HEPMET-1 Evaluate the Feasibility Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group
Sponsor:
Sorlandet Hospital HF
Organization:
Sorlandet Hospital HF
Study Overview
Official Title:
HEPMET-1 Evaluate the Feasibility Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated MMT Opioid Addicted Group
Status:
COMPLETED
Status Verified Date:
2008-03
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:
To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a PEG-INF and ribavirin to the same extent than non-opioid dependents
To determine the efficacy of this anti-HCV treatment
To determine the efficacy of this anti-HCV treatment
Detailed Description:
Chronic infection with the hepatitis C virus HCV is a health problem worldwide In Norway there are about 3000 patients participating in Methadone Maintenance TreatmentMMT programs A prevalence study at the MMT treatment unit in Kristiansand showed that more than 90 of 177 patients have been infected with hepatitis C
A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment Further due to the high incidence of psychological disorders in opioid dependent patients this may also complicate anti-HCV treatment Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment
Due to better treatment efficacy with the new PEG-INFs and encouraging reports from 14 weeks studies it may be easier to motivate opioid dependents to fulfill treatment Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment
The aim of this study is to focus on this patients situation and strengthen their possibility to have a real opportunity to get treatment We therefore wish to make a pilot study to investigate the feasibility efficacy and psycological side-effects of the treatment
A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment Further due to the high incidence of psychological disorders in opioid dependent patients this may also complicate anti-HCV treatment Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment
Due to better treatment efficacy with the new PEG-INFs and encouraging reports from 14 weeks studies it may be easier to motivate opioid dependents to fulfill treatment Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment
The aim of this study is to focus on this patients situation and strengthen their possibility to have a real opportunity to get treatment We therefore wish to make a pilot study to investigate the feasibility efficacy and psycological side-effects of the treatment
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 |
|---|---|---|---|
| EudraCT no 2005-002869-37 | None | None | None |
| Protocol no 9772387 | None | None | None |