Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
NCT ID: NCT00062816
Last Updated: 2022-12-05
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2003-06-30
2004-01-31
Brief Summary
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Detailed Description
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In this clinical research study, 12 weeks of ISIS 14803 treatment will be added to the peginterferon alfa and ribavirin treatment regimen of previously untreated chronic hepatitis C patients who have a very poor probability of achieving a sustained virologic response based upon either of the above two criteria. Enrolled patients must continue to be treated with peginterferon alfa and ribavirin and must begin ISIS 14803 treatment within four weeks of their HCV RNA result report date. ISIS 14803 will be given as a two-hour intravenous infusion, two times each week, for 12 weeks. Depending on their HCV response to the three-drug combination, patients may continue treatment with peginterferon alfa and ribavirin after the end of ISIS 14803 treatment. Patients will be monitored for at least eight weeks (for safety) after the end of ISIS 14803 treatment and possibly for longer (for sustained virologic response). Two dose levels of ISIS 14803 will be studied in this trial, 3 and 6 mg/kg ideal body weight.
Conditions
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Study Design
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TREATMENT
Interventions
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ISIS 14803, peginterferon alfa, ribavirin
Eligibility Criteria
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Inclusion Criteria
* Infection with HCV.
* Prior liver biopsy indicating chronic hepatitis.
* Received at least 12 weeks of continuous peginterferon alfa and ribavirin therapy.
* HCV infection was untreated prior to current peginterferon alfa and ribavirin regimen.
* Either less than 100-fold reduction in plasma or serum HCV RNA despite receiving 12 weeks of peginterferon alfa and ribavirin therapy or detectable HCV RNA at week 24 of therapy.
* Prothrombin time and aPTT within normal reference range.
* Serum bilirubin concentration within normal reference range.
* Give written informed consent to participate in the study.
Exclusion Criteria
* Systemic corticosteroid therapy within 3 months of screening.
* Serum ALT greater than 5 x upper limit of normal range.
* HIV or HBV infection.
* Decompensated liver disease.
* Evidence of cirrhosis.
* Severe depression with suicidal ideation requiring hospitalization within one year of screening.
* Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin.
* Any condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance.
* Alcohol or drug abuse.
* Is undergoing or has undergone treatment with another investigational drug, biologic agent or device within 30 days of screening
* History of cryoglobulinemia or vasculitis
18 Years
65 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Community Clinical Trials
Orange, California, United States
The Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
University of Florida
Jacksonville, Florida, United States
Miami Research Associates, Inc.
Miami, Florida, United States
Idaho Gastroenterology Assoc.
Boise, Idaho, United States
IMG Healthcare, LLC
New Orleans, Louisiana, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States
FutureCare Studies
Springfield, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Cornell Medical Center
New York, New York, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Blair Gastroenterology Associates
Altoona, Pennsylvania, United States
Gastroenterology Center of the MidSouth, P.C.
Germantown, Tennessee, United States
Memphis Gastroenterology Group
Memphis, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine-VAMC
Houston, Texas, United States
McGuire VAMC
Richmond, Virginia, United States
Northwest Gastroenterolgy Assoc.
Bellevue, Washington, United States
Spokane Digestive Disease Center
Spokane, Washington, United States
Countries
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Other Identifiers
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ISIS 14803-CS3
Identifier Type: -
Identifier Source: org_study_id
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