Hepatitis C Among Opioid Addicts in Opioid Maintenance Tr... | NCT00473993

Studies
Hepatitis C Among Opioid Addicts in Opioid Maintenance Treatment in Zurich, Switzerland

NCT00473993

Sponsor

Seidenberg, Arztpraxis A., M.D.

Status

Completed

Last Update Posted

Feb 16, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Hepatitis C, Chronic
Substance Abuse Treatment Centers
Opioid-Related Disorders

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

May 15, 2007

First Submission Date that Met QC Criteria

May 15, 2007

First Posted Date

May 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2009

Last Update Posted Date

Feb 16, 2009Estimated

Name	Class
University of Zurich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to the results of the treatment of nonaddicts.

Our crossectional study investigates how many patients undergoing OMT are adequately investigated concerning hepatitis C. If not, why are they not adequately investigated and treated? Representative data are collected in the local clinics and medical practices involved in OMT in the Kanton of Zurich. The patients files are revised and the involved doctors are asked through a structured interview.

Detailed Description

www.seidenberg.ch/hepcop.pdf

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medical practices and clinics involved in opioid maintenance treatment in the Kanton of Zurich, Switzerland

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients in opioid maintenance treatment in the kanton of Zurich, Switzerland

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
André Seidenberg, Dr.med.	research fellow EHAM, University of Zurich	Study Director

Locations

Not provided

Label	URL
download of the protocol of the HepCOP-study	View source

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D009293	Opioid-Related Disorders
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided