Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00751426
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2008-09-11
Brief Title:
Treatment of Hepatitis C in Psychiatric Patients
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin a Comparison of Patients With Psychiatric Disorders and Controls
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Psychiatric disorders or drug addiction are often regarded as contraindications against the use of Interferon-alpha in patients with chronic hepatitis C The investigators aim iswas to get prospective data about adherence efficacy and mental side effects of IFN-alpha treatment in different psychiatric risk groups compared to controls In a prospective trial 81 patients with chronic hepatitis C positive HCV-RNA and elevated ALT and psychiatric disorders n16 methadone substitution n21 former drug addiction n21 or controls without psychiatric history or addiction n23 should bewere treated with a combination of IFN-alpha-2a 3 x 3 Mio Uweek and ribavirin 1000-1200 mgday
Detailed Description:
Patients from the Munich University outpatient department of psychiatry or gastroenterology as well as inpatients with elevated transaminases were tested for HCV-infection and considered for our trial to avoid a positive or negative selection Medical inclusion criteria were a detectable serum HCV-RNA level in a PCR-based assay AMPLICOR Roche Diagnostics Branchburg NJ for more than 6 months and an elevated alanine aminotransferase ALT 30 UL normal 24 UL General exclusion criteria were the presence of other liver disease Child B or C cirrhosis severe cardiac or neurological disease co-infection with hepatitis B or HIV hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein autoimmune disorders a neutrophil count below 1500 per cubic millimetre and a platelet count below 75000 per cubic millimetre
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