HEPMET-1: Evaluate the Feasibility, Mental Sideeffects an... | NCT00147784

Studies
HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.

NCT00147784

Sponsor

Sorlandet Hospital HF

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

10Estimated

Phase

Phase 3

Conditions

Opiate Dependence
Hepatitis

Interventions

Ribavirin
Pegylated Interferon

Countries

Norway

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

Mar 2008

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

Mar 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 7, 2005Estimated

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

Mar 26, 2008

Last Update Posted Date

Mar 28, 2008Estimated

Description Module

Brief Summary

To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.
To determine the efficacy of this anti-HCV treatment

Detailed Description

Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C.

A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment.

Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment.

The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug	800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
Pegylated Interferon	Drug	180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment		24 weeks after end of treatment

Secondary Outcomes

Measure	Description	Time Frame
Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology		2, 4, 8, 14 and 24 weeks after study start

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Serologic evidence of hepatitis C infection, genotype 2 and 3
Normal or elevated serum ALT activity
In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.
Male and female patients

Exclusion Criteria:

Women with ongoing pregnancy or breast feeding
Untreated serious psychiatric disorders, particularly depression.
Serious drug abuse or alcohol abuse last 6 months
Intravenous drug abuse last 6 months
Hepatitis A, B or HIV infection
HCV genotype 1, 4, 5 and 6
Leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
Platelet count < 80 000 cells/mm3 at screening
Hb <11 g/dL in women or <12 g/dL in men at screening
Documented or presumed coronary artery disease or cerebrovascular disease
Thyroid dysfunction not adequately controlled
Epilepsy
Malignant disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oistein Kristensen, MD	Soerlandet Hospital HF	Principal Investigator
Oistein Kristensen, MD	Addiction Unit, SSHF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soerlandet Hospital HF		Kristiansand	Vest-Agder	4604	Norway
Addiction Unit, Sorlandet Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19721480	Derived	Kristensen O, Sundoy A, Skeie K, Vederhus JK, Oye I, Opsal A, Rysstad O, Gallefoss F. [Short-term treatment of Hepatitis C in heroin-dependent patients]. Tidsskr Nor Laegeforen. 2009 Aug 27;129(16):1639-42. doi: 10.4045/tidsskr.09.33690. Norwegian.

ID	Term
D009293	Opioid-Related Disorders
D006505	Hepatitis

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Type	Description	Link
Protocol no 9772387
EudraCT no 2005-002869-37