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

Hepatitis Clinical Trial

Official title:

HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147784
• Other study ID #: SSHF-70332
• Secondary ID: Protocol no 9772
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: March 26, 2008
• Start date: March 2006
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Opiate Dependence

Intervention

Drug:
• Ribavirin
800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
• Pegylated Interferon
180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

Locations

Country	Name	City	State
Norway	Addiction Unit, Sorlandet Hospital	Kristiansand	Vest-Agder
Norway	Soerlandet Hospital HF	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment		24 weeks after end of treatment	No
Secondary	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	No