Status:
WITHDRAWN
Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
Lead Sponsor:
University of Wuerzburg
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-65 years
Brief Summary
Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany. Aims: \- Primary objective: To compare the impact of the different substitution drugs (met...
Eligibility Criteria
Inclusion
- Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
- Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin.
- Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
- Patients with baseline monitoring of emotional state and neurocognitive performance.
Exclusion
- According to SPC
- According to legal requirements reg. drug substitution therapy (BTMVV)
- Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance).
- Age under 18 years or over 65 years
- coinfections such as hepatitis B virus or human immunodeficiency virus
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00682591
Start Date
July 1 2008
End Date
December 1 2011
Last Update
February 4 2009
Active Locations (1)
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1
Med. Klinik und Poliklinik II, University of Wuerzburg
Würzburg, Germany, 97070