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Hepatitis CPhase 4NCT01045278

Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy

A Phase 4 study testing Pegylated interferon-alfa-2b and ribavirin in people with Hepatitis C, run by Region Skane at 1 site in Sweden.

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

Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is the most common indication for liver transplantation. In the Western world, the absolute majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable narcotic drugs. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hepatitis C
What is being tested?
Pegylated interferon-alfa-2b and ribavirin
Type of treatment
Injection or infusion
How many people
277 participants
Where
1 siteSweden
Study dates
Apr 2008to Sep 2013
Phase
Phase 4
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients that meet all of the following inclusion criteria are eligible for part I of the study:
  • Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
  • Written informed consent for part I of the study.
  • Patients that meet all of the following inclusion criteria are eligible for part II of the study:
  • Fulfilled part I
  • Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
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  • HCV-PCR positive.
  • Written informed consent for part II of the study.
  • Patients that meet all of the following inclusion criteria are eligible for part III of the study:
  • Fulfilled part II
  • Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
  • HCV-PCR positive.
  • Written informed consent for part III of the study and able to adhere to dosing and visiting schedules.
  • At least 6 months of uninterrupted maintenance therapy for opiate dependence.
  • Treatment indication with at least one of the following:
  • Fibrosis/cirrhosis
  • Other HCV related disease/symptoms
  • Psychological indication
  • For patients with cirrhosis, an ultrasound investigation should be performed within six months before study initiation, part III, (not showing signs of HCC).
  • Use of adequate contraception during the treatment period and for six months after the completion of therapy (for all participants regardless of gender).

Who cannot join

  • The presence of any of the following criteria will exclude the patient from participating in part III of the study:
  • Pregnant women, women who plan to become pregnant, male patients whose partner wants to become pregnant, and breastfeeding women.
  • Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination.
  • Participation in another clinical drug trial.
  • Coinfection with HBV or HIV
  • Hemoglobin <120 g/L for females and <130 g/L for males.
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  • LPK <3,0 x 109/L
  • Platelets <80 x 109/L
  • Creatinin clearance <50mL/min
  • Any of the following diseases considered to be a dominant cause of the patients chronic liver disease:
  • Hemochromatosis
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Non-alcoholic steatohepatitis (NASH)
  • Drug-related liver disease
  • Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
  • Patients with organ transplants, except for corneal or hair transplant.
  • Poorly controlled diabetes mellitus.
  • Evidence of severe retinopathy or clinically relevant ophthalmological disorder in patients with diabetes mellitus or hypertension.
  • Poorly controlled epilepsy.
  • Thyroid dysfunction not adequately controlled
  • Decompensated cirrhosis (Child-Pugh B-C).
  • Treatment with immunomodulatory drugs (chronic systemic corticosteroids (equivalent to >10 mg prednisone/day), immunosuppressive drugs, chemotherapy) and/or treatment with herbal drugs for chronic hepatitis.
  • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Skåne university hospital

    Malmö

Other trials in Sweden

About this study

Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is the most common indication for liver transplantation. In the Western world, the absolute majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable narcotic drugs. Most injecting drug users contract HCV infection within the first years after starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of patients registered in clinics providing maintenance therapy for opiate dependence in three metropolitan areas of Sweden. The cohort is defined as all patients registered in these three clinics at the date of study initiation. The study contains four parts:

Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the cohort and the proportion of anti-HCV positive participants with chronic infection.

Read more

Part II: Patients with chronic HCV infection will be offered further investigation of chronic liver disease, including liver biopsy, for selection of candidates for antiviral therapy and identification of risk factors for development of severe liver disease.

Part III: Based on the results of these investigations, patients will be considered for antiviral therapy. Indications for such therapy will mainly be clinical and/or histological signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of pegylated interferon-alfa-2b and ribavirin.

Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to part III.

Conditions
Hepatitis C
Being tested
Pegylated interferon-alfa-2b and ribavirin
Keywords
Hepatitis C patients, Hepacivirus
Medical subject headings
Hepatitis C

What participants receive

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

  • Pegylated interferon-alfa-2b and ribavirinDrug

    Pegylated interferon-alfa-2b 1.5 microg/kg subcutaneously once weekly plus weight based ribavirin 800-1200 mg PO for a variable period depending on their HCV genotype and response to treatment.

What is being measured

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

  1. To determine the completion rates of HCV treatment with pegylated interferon-alfa-2b and ribavirin in patients who are under opiate maintenance treatment and eligible for HCV therapy.

    Measured: 14-72 weeks

Secondary outcomes (8)

  1. Prevalence of chronic HCV infection in the patient population eligible for part I in the study.

    Measured: Screening visit (first visit of the study).

  2. Clinical and histological characteristics of chronic hepatitis C.

    Measured: Liver investigation visit (second visit of the study). No time frame specified in the protocol.

  3. Prevalence of hepatic decompensation and cirrhosis/advanced liver disease.

    Measured: Liver investigation visit (second visit of the study). No time frame specified in the protocol.

  4. Risk factors for advanced liver disease.

    Measured: Liver investigation visit (second visit of the study). No time frame specified in the protocol.

  5. Proportion of sustained virological responders, defined as a plasma HVC RNA level below Lower Level of Quantification at 24 week post-treatment.

    Measured: 24 weeks post-treatment.

  6. Rates of relapse in opiate drug abuse.

    Measured: Treatment period (14-72 weeks) and up till 24 weeks post-treatment.

  7. Prevalence of depressive symptoms and assessment of quality of life before, under and after HCV treatment.

    Measured: Treatment period (14-72 weeks) and up to 24 weeks post-treatment.

  8. Potential pharmacokinetic interactions between ribavirin and methadone or buprenorphine.

    Measured: Measured after 4 weeks treatment.

Timeline

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

  1. First posted11 Jan 2010 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01045278
Sponsor's protocol ID
EU-nr 2007-001130-13
Status last verified
Oct 2013
First submitted
11 Sep 2009
Last updated
7 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegylated interferon-alfa-2b and ribavirin in people with Hepatitis C, run by Region Skane at 1 site in Sweden.

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 20 inclusion and 26 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 7 Oct 2013. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

To determine the completion rates of HCV treatment with pegylated interferon-alfa-2b and ribavirin in patients who are under opiate maintenance treatment and eligible for HCV therapy. (time frame: 14-72 weeks). 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 NCT01045278.

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 7 Oct 2013.

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