Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Ribavirin

Criteria

Inclusion Criteria (partial list):

• 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.

Exclusion criteria (partial list):

• 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