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Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C
This study is ongoing, but not recruiting participants.
First Received: September 13, 2005   Last Updated: June 9, 2008   History of Changes
Sponsors and Collaborators: University of Calgary
Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00203606
  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 70 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 IV

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title: Effectiveness of Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C

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: 70
Study Start Date: January 2004
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: pegylated interferon alfa-2a ( Roche) and ribavirin
pegylated interferon alfa-2a ( Roche) and ribavirin
2: No Intervention

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. We will compare the results of treatment of 70 active drug users to 70 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.

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

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N4N1
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Investigators
Principal Investigator: Robert J Hilsden, MD PhD University of Calgary
  More Information

No publications provided

Responsible Party: University of Calgary ( Robert Hilsden )
Study ID Numbers: 21995
Study First Received: September 13, 2005
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00203606     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Antimetabolites
Interferon-alpha
Liver Diseases
Immunologic Factors
Ribavirin
Interferons
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a

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

ClinicalTrials.gov processed this record on May 07, 2009