Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT00062816
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to patients who either failed to have at least a 100-fold HCV reduction at Week 12 of standard therapy or still have detectable HCV at Week 24.
- Detailed Description
Previously untreated chronic hepatitis C patients undergoing therapy with peginterferon alfa and ribavirin have a very poor probability of achieving a sustained virologic response if they either do not have a 100-fold or greater reduction in their plasma HCV RNA levels at the 12th week of treatment or have detectable plasma HCV RNA at the 24th week of treatment. ISIS 14803 is an experimental antiviral medication for the treatment of chronic hepatitis C that has been given to chronic hepatitis C patients in two previous single-agent clinical trials (approximately 70 patients).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
University of Florida
🇺🇸Jacksonville, Florida, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Baylor College of Medicine-VAMC
🇺🇸Houston, Texas, United States
Duke Clinical Research Institute
🇺🇸Durham, North Carolina, United States
Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
IMG Healthcare, LLC
🇺🇸New Orleans, Louisiana, United States
FutureCare Studies
🇺🇸Springfield, Massachusetts, United States
Miami Research Associates, Inc.
🇺🇸Miami, Florida, United States
Idaho Gastroenterology Assoc.
🇺🇸Boise, Idaho, United States
Memphis Gastroenterology Group
🇺🇸Memphis, Tennessee, United States
Beth Israel Deconess Medical Center
🇺🇸Boston, Massachusetts, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
🇺🇸Rochester, New York, United States
Northwest Gastroenterolgy Assoc.
🇺🇸Bellevue, Washington, United States
Cornell Medical Center
🇺🇸New York, New York, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
McGuire VAMC
🇺🇸Richmond, Virginia, United States
Western States Clinical Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Blair Gastroenterology Associates
🇺🇸Altoona, Pennsylvania, United States
Gastroenterology Center of the MidSouth, P.C.
🇺🇸Germantown, Tennessee, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Spokane Digestive Disease Center
🇺🇸Spokane, Washington, United States
The Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States