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

December 1, 2022 updated by: Ionis Pharmaceuticals, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Orange, California, United States, 92868
        • Community Clinical Trials
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • The Lynn Institute of The Rockies
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research, Inc.
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Miami, Florida, United States, 33173
        • Miami Research Associates, Inc.
    • Idaho
      • Boise, Idaho, United States, 83702
        • Idaho Gastroenterology Assoc.
    • Louisiana
      • New Orleans, Louisiana, United States, 70127
        • IMG Healthcare, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deconess Medical Center
      • Springfield, Massachusetts, United States, 01107
        • FutureCare Studies
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
    • New York
      • New York, New York, United States, 10021
        • Cornell Medical Center
      • Rochester, New York, United States, 14607
        • Rochester Institute for Digestive Diseases and Sciences, Inc.
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Clinical Research Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Gastroenterology Associates
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastroenterology Center of the Midsouth, P.C.
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology Group
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-VAMC
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VAMC
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Gastroenterolgy Assoc.
      • Spokane, Washington, United States, 99207
        • Spokane Digestive Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

June 16, 2003

First Submitted That Met QC Criteria

June 17, 2003

First Posted (Estimate)

June 18, 2003

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 14803-CS3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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