ISIS 14803-CS2, Treatment With ISIS 14803, Administered IV in Patients With Chronic Hepatitis C Virus Infections

Phase 2

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00035945
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

Purpose of this study is to evaluate the safety, tolerability, antiviral activity, and pharmacokinetic behavior of ISIS 14803 administered for up to 12 weeks by intravenous infusions in patients with chronic hepatitis C.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10-01
• Study First Submitted: 2002-05-06
• Study First Submitted QC: 2002-05-07
• Study First Posted: 2002-05-08
• Primary Completion: 2004-05-01
• Study Completion: 2004-05-01
• Status Verified: 2007-10
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with any of the following criteria during screening will not be eligible:

• Human immunodeficiency virus (HIV) infection (Western immunoblot confirmed presence of anti-HIV antibodies or detection of HIV RNA in blood).
• Chronic hepatitis B virus (HBV) infection (HBV surface antigen or DNA in blood).
• Antiviral therapy for HCV within 3 months.
• Immunomodulatory therapy (e.g., systemic corticosteriods or interferon) within 3 months.
• Advanced or decompensated liver disease (e.g., history of bleeding varices, spontaneous hepatic encephalopathy, ascites) of any etiology such as alcohol, drug, obesity, or hemochromatosis.
• ALT greater than 5x ULN.
• Histologic evidence of cirrhosis.
• Presence of an underlying disease state associated with active bleeding.
• Undergoing therapeutic anticoagulation with heparin or warfarin.
• Presence of any other active infection requiring therapy.
• Presence of malignancy.
• Presence or history of any significant medical illness that might interfere with this study.
• Receipt of an investigational new drug, biological or therapeutic device within 30 days of study entry.
• Alcohol or drug abuse requiring medical intervention within 2 years.
• History of non-compliance with prescribed medical care.
• Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Isis Pharmaceuticals; 🇺🇸 Carlsbad, California, United States