Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Roche Pharma AG
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00203606
First received: September 13, 2005
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

Hepatitis C infects as many as 300,000 Canadians. Up to 25% of those infected will develop cirrhosis and be at risk for liver failure and liver cancer. Cirrhosis caused by hepatitis C is the most common reason for liver transplantation in Canada. The largest group of infected people are those who use injectable street drugs. However, people who continue to use drugs are routinely excluded from scientific studies testing new treatments for Hepatitis C and are generally recommended not to receive available treatments. Although several reasons are given to justify excluding these people from treatment, little scientific evidence is available to support it. We plan to examine how successful treatment with the current standard treatment of pegylated interferon and ribavirin is in those who continue to use injection drugs. We will compare the results of treatment of 70 active drug users to results of published clinical trials (this is a change from initial plan to compare to treatment results of 70 local) reformed drug users). Our goal is to determine whether reasonable success rates can be achieved in active drug users that would then further justify their routine treatment.


Condition Intervention Phase
Hepatitis c
Drug: pegylated interferon alfa-2a ( Roche) and ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Sustained viral response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2004
Study Completion Date: August 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
Active Treatment with Pegylated Interferon Alfa 2a (Pegasys, Roche) and ribavirin
Drug: pegylated interferon alfa-2a ( Roche) and ribavirin
pegylated interferon alfa-2a ( Roche) and ribavirin
No Intervention: Observation
Observation with no active treatment for Hepatitis C. Observation period is based on standard treatment duration based on genotype of Hepatitis C. Active treatment offered to participants at conclusion of observation. (Protocol Amendment #1, October 30, 2001. Ethics approval Jan 19, 2004).

Detailed Description:

We plan to examine how successful treatment with the current standard treatment of pegylated interferon and ribavirin is in those who continue to use injection drugs. Our goal is to determine whether reasonable success rates can be achieved in active drug users that would then further justify their routine treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women age 18 to 75 years.
  2. Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA at least 6 months prior to study entry.
  3. Positive HCV-RNA by Roche Amplicor HCV test at screening
  4. Serum ALT > 1.5 times upper limit of normal
  5. Active or past use of injection drugs or crack cocaine by self-report. Active use is defined as injection drug use at least 1/month and within 3 months of the date of randomization. Past use is defined as no injection drug use or crack cocaine use within the past 5 years.
  6. Compensated liver disease
  7. Negative urine or blood pregnancy tests (for women of childbearing potential) documented within 24-hours prior to first dose of study drug.
  8. All fertile males and females must use effective contraception during treatment and during the 6 months after treatment end if sexually active (This will be provided free of charge to active IDUs).

Exclusion Criteria:

  1. Presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of variceal bleeding within the last two years.
  2. Platelet count < 60,000/mm3
  3. Serum ALT level > 10 times upper limit of normal
  4. Serum creatinine level > 1.5 times the upper limit of normal (Deleted February 27, 2007, Protocol Amendment #4, Ethics approval March 28, 2007)
  5. Hematology outside of specified limits: neutrophil count < 1000/mm3, hemoglobin < 10 g/L in males and < 9 g/L in females

7. Unstable or uncontrolled thyroid disease 8. Treatment with interferon- and/or ribavirin within the previous 12 months 9. Presence of clinically significant cryoglobulinemia vasculitis (e.g. skin rash, arthritis, or renal insufficiency due to cryoglobulinemia) 10. Presence or history of autoimmune hepatitis, alpha-1-anti-trypsin deficiency, genetic hemochromatosis, Wilson disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis.

11. Chronic hepatitis B infection or positive HbsAg at screening 12. Known history of HIV infection or positive HIV antibody test by Western Blot.

13. A disease known to cause significant alteration in immunologic function, including hematological malignancy or autoimmune disorder.

14. Concurrent therapy with immunosuppressive drugs or cytotoxic agents, such as prednisone, cyclosporine, azathioprine or chemotherapeutic agents.

15. History of unstable or deteriorating cardiac, pulmonary or renal disease. 16. Preexisting (within last two years) or active psychiatric condition including severe untreated depression, major psychoses, suicidal ideation or suicidal attempts.

17. Severe or poorly controlled diabetes mellitus 18. Any serious or chronic disease that may affect the assessment of safety or efficacy parameters.

19. Patients who have had a liver transplant 20. Patients infected with HCV genotypes 4, 5 or 6 (< 1% of infected current/past IDUs)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203606

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N4N1
Canada, British Columbia
Pender Clinic
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Roche Pharma AG
Investigators
Principal Investigator: Robert J Hilsden, MD PhD University of Calgary
  More Information

No publications provided

Responsible Party: Robert Hilsden, University of Calgary
ClinicalTrials.gov Identifier: NCT00203606     History of Changes
Other Study ID Numbers: 21995
Study First Received: September 13, 2005
Last Updated: August 3, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015