Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
1 other identifier
interventional
22
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2003
Shorter than P25 for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 16, 2003
CompletedFirst Posted
Study publicly available on registry
June 18, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedDecember 5, 2022
October 1, 2007
7 months
June 16, 2003
December 1, 2022
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years.
- 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.
You may not qualify if:
- Pregnant women or nursing mothers or women of childbearing potential without adequate contraception.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Community Clinical Trials
Orange, California, 92868, United States
The Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
University of Florida
Jacksonville, Florida, 32209, United States
Miami Research Associates, Inc.
Miami, Florida, 33173, United States
Idaho Gastroenterology Assoc.
Boise, Idaho, 83702, United States
IMG Healthcare, LLC
New Orleans, Louisiana, 70127, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
FutureCare Studies
Springfield, Massachusetts, 01107, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Cornell Medical Center
New York, New York, 10021, United States
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, 14607, United States
Duke Clinical Research Institute
Durham, North Carolina, 27705, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Blair Gastroenterology Associates
Altoona, Pennsylvania, 16602, United States
Gastroenterology Center of the MidSouth, P.C.
Germantown, Tennessee, 38138, United States
Memphis Gastroenterology Group
Memphis, Tennessee, 38120, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Baylor College of Medicine-VAMC
Houston, Texas, 77030, United States
McGuire VAMC
Richmond, Virginia, 23249, United States
Northwest Gastroenterolgy Assoc.
Bellevue, Washington, 98004, United States
Spokane Digestive Disease Center
Spokane, Washington, 99207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2003
First Posted
June 18, 2003
Study Start
June 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
December 5, 2022
Record last verified: 2007-10