Chronic Hepatitis C InfectionNCT00682591
Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
An observational study of Chronic Hepatitis C Infection, run by University of Wuerzburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C Infection
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Med. Klinik und Poliklinik II, University of Wuerzburg
Würzburg, 97070
About this study
Official title: 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)
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
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- hepatitis C, drug substitution, neurocognitive, patients with stable drug substitution therapy, patients with interferon-based antiviral therapy
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
Measured: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Study had to be withdrawn because financial support was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Investigators
- Michael Scheurlen, MD, Principal investigator, Med. Klinik und Poliklinik II, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682591
- Sponsor's protocol ID
- P05595
- Status last verified
- Feb 2009
- First submitted
- 20 May 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. doi: 10.1016/j.clpt.2004.09.007.
PubMed 15637534Schafer A, Scheurlen M, Weissbrich B, Schottker K, Kraus MR. Sustained virological response in the antiviral therapy of chronic hepatitis C: is there a predictive value of interferon-induced depression? Chemotherapy. 2007;53(4):292-9. doi: 10.1159/000102584. Epub 2007 May 10.
PubMed 17496415Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614.
PubMed 12823087Schafer A, Wittchen HU, Seufert J, Kraus MR. Methodological approaches in the assessment of interferon-alfa-induced depression in patients with chronic hepatitis C - a critical review. Int J Methods Psychiatr Res. 2007;16(4):186-201. doi: 10.1002/mpr.229.
PubMed 18188838
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00682591
- Acronym / sponsor ID
- P05595
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- hepatitis C, drug substitution, neurocognitive, patients with stable drug substitution therapy, patients with interferon-based antiviral therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study had to be withdrawn because financial support was cancelled.
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
Time frame: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Background: PubMed 15637534Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. doi: 10.1016/j.clpt.2004.09.007.
- Background: PubMed 17496415Schafer A, Scheurlen M, Weissbrich B, Schottker K, Kraus MR. Sustained virological response in the antiviral therapy of chronic hepatitis C: is there a predictive value of interferon-induced depression? Chemotherapy. 2007;53(4):292-9. doi: 10.1159/000102584. Epub 2007 May 10.
- Background: PubMed 12823087Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614.
- Background: PubMed 18188838Schafer A, Wittchen HU, Seufert J, Kraus MR. Methodological approaches in the assessment of interferon-alfa-induced depression in patients with chronic hepatitis C - a critical review. Int J Methods Psychiatr Res. 2007;16(4):186-201. doi: 10.1002/mpr.229.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Scheurlen, MD principal investigator
Med. Klinik und Poliklinik II, University of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C Infection, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance) (time frame: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682591, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.