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Opiate DependencePhase 3NCT00147784

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

A Phase 3 study testing Ribavirin and Pegylated Interferon in people with Opiate Dependence and Hepatitis, run by Sorlandet Hospital HF at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Opiate Dependence, Hepatitis
What is being tested?
Ribavirin and Pegylated Interferon
How many people
10 participants
Where
2 sitesNorway
Study dates
Mar 2006to Jan 2008
Phase
Phase 3
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 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Soerlandet Hospital HF

    Kristiansand, Vest-Agder, 4604

  • Addiction Unit, Sorlandet Hospital

    Kristiansand, Vest-Agder, N-4604

Other trials in Norway

About this study

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.

  • 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
Read the 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.

Being tested
Ribavirin, Pegylated Interferon
Keywords
Chronical Hepatitis C treatment, Methadone Maintenance Treatment, Pegylated Interferon and Ribavirin, 14 weeks treatment, Genotype 2 and 3
Medical subject headings
Opioid-Related Disorders, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibavirinDrug

    800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks

  • Pegylated InterferonDrug

    180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. - Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment

    Measured: 24 weeks after end of treatment

Secondary outcomes (1)

  1. Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology

    Measured: 2, 4, 8, 14 and 24 weeks after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startMar 2006
  3. Primary completionJun 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147784
Sponsor's protocol ID
SSHF-70332
Other IDs
Protocol no 9772387, EudraCT no 2005-002869-37
Status last verified
Mar 2008
First submitted
6 Sep 2005
Last updated
28 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 19721480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribavirin and Pegylated Interferon in people with Opiate Dependence and Hepatitis, run by Sorlandet Hospital HF at 2 sites in Norway.

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 13 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: finished, as of the sponsor's last update on 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment (time frame: 24 weeks after end of 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 NCT00147784, which also lists 1 linked publication.

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 28 Mar 2008.

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