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Trial record 96 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

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

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ClinicalTrials.gov Identifier: NCT01045278
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
Region Skane

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE January 11, 2010
Last Update Posted Date October 7, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01045278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Prevalence of chronic HCV infection in the patient population eligible for part I in the study. [ Time Frame: Screening visit (first visit of the study). ]
  • Clinical and histological characteristics of chronic hepatitis C. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
  • Prevalence of hepatic decompensation and cirrhosis/advanced liver disease. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
  • Risk factors for advanced liver disease. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ]
  • Proportion of sustained virological responders, defined as a plasma HVC RNA level below Lower Level of Quantification at 24 week post-treatment. [ Time Frame: 24 weeks post-treatment. ]
  • Rates of relapse in opiate drug abuse. [ Time Frame: Treatment period (14-72 weeks) and up till 24 weeks post-treatment. ]
  • Prevalence of depressive symptoms and assessment of quality of life before, under and after HCV treatment. [ Time Frame: Treatment period (14-72 weeks) and up to 24 weeks post-treatment. ]
  • Potential pharmacokinetic interactions between ribavirin and methadone or buprenorphine. [ Time Frame: Measured after 4 weeks treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy
Official Title  ICMJE Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy
Brief 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. 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.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: Pegylated interferon-alfa-2b and ribavirin
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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2013)
277
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2010)
450
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients that meet all of the following inclusion criteria are eligible for part I of the study:

    1. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    2. 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:

    1. Fulfilled part I
    2. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    3. HCV-PCR positive.
    4. 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:

    1. Fulfilled part II
    2. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    3. HCV-PCR positive.
    4. Written informed consent for part III of the study and able to adhere to dosing and visiting schedules.
    5. At least 6 months of uninterrupted maintenance therapy for opiate dependence.
    6. Treatment indication with at least one of the following:

      • Fibrosis/cirrhosis
      • Other HCV related disease/symptoms
      • Psychological indication
    7. For patients with cirrhosis, an ultrasound investigation should be performed within six months before study initiation, part III, (not showing signs of HCC).
    8. Use of adequate contraception during the treatment period and for six months after the completion of therapy (for all participants regardless of gender).

Exclusion Criteria:

  • The presence of any of the following criteria will exclude the patient from participating in part III of the study:

    1. Pregnant women, women who plan to become pregnant, male patients whose partner wants to become pregnant, and breastfeeding women.
    2. Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination.
    3. Participation in another clinical drug trial.
    4. Coinfection with HBV or HIV
    5. Hemoglobin <120 g/L for females and <130 g/L for males.
    6. LPK <3,0 x 109/L
    7. Platelets <80 x 109/L
    8. Creatinin clearance <50mL/min
    9. 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
    10. Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
    11. Patients with organ transplants, except for corneal or hair transplant.
    12. Poorly controlled diabetes mellitus.
    13. Evidence of severe retinopathy or clinically relevant ophthalmological disorder in patients with diabetes mellitus or hypertension.
    14. Poorly controlled epilepsy.
    15. Thyroid dysfunction not adequately controlled
    16. Decompensated cirrhosis (Child-Pugh B-C).
    17. 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.
    18. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01045278
Other Study ID Numbers  ICMJE EU-nr 2007-001130-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anna Jerkeman, MD Skane University Hospital
PRS Account Region Skane
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP