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Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy | Clinical Trials | Clareo Health

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Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients (Methadone, Buprenorphine, Suboxone) Under Hepatitis C Therapy (Peginterferon Alfa and Ribavirin)

NCT00682591•University of Wuerzburg

View on ClinicalTrials.gov

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 (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment. \- Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Med. Klinik und Poliklinik II, University of Wuerzburg

Würzburg, Germany

Key Dates

Start Date

July 1, 2008

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

February 4, 2009

Enrollment

190

ESTIMATED participants

Conditions

Chronic Hepatitis C Infection

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

NCT01866930

Chronic Hepatitis C Infection

View study

COMPLETED

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

NCT02333292

Chronic Hepatitis C Infection

View study

COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects