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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
    • California
      • Carlsbad, California, United States, 92008
        • Isis Pharmaceuticals

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must meet the following inclusion criteria during screening:

  • Age greater than or equal to 18 years.
  • Both males and females are eligible. All patients should be advised that there are no data on the possible reproductive (teratological) effects of ISIS 14803.

Therefore:

  • a) Females may participate if they are surgically sterile or post-menopausal. Pre-menopausal women may participate if they are abstinent or are compliant with a contraceptive regimen. Abstinence or contraceptive regimen must be maintained during the treatment period and for 4 weeks after discontinuation of therapy. A negative serum pregnancy test (i.e., human chorionic gonadotropin, hCG) within 2 weeks prior to dosing with ISIS 14803 is required for pre-menopausal women. Subjects must not be breast feeding.
  • b) Male patients must be surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during the treatment period and for 4 weeks after discontinuation of therapy.
  • Anti-HCV antibody positive.
  • Plasma HCV RNA greater than 10,000 copies/mL.
  • Prior liver biopsy indicating chronic hepatitis.
  • WBC count less than or equal to upper limit of normal.
  • Absolute neutrophil count in normal range for the laboratory.
  • Platelet count greater than 130,000 cells/mm³.
  • Hemoglobin concentration greater than or equal to 11 g/dL.
  • PT in the normal range for the laboratory.
  • Normal aPTT.
  • Bilirubin in the normal range unless due to documented Gilbert's disease.
  • Serum creatinine less than or equal to 1.5 times the upper limit of the normal range.
  • Urinalysis showing no evidence of infection or active renal disease (e.g., proteinuria).
  • Subjects must be able to adhere to the visit schedule set forth in this protocol.
  • Written informed consent prior to the performance of any study related procedures.

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 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ionis Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Elan Pharmaceuticals
Hepasense

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2001

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2004

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2002

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2002

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISIS 14803-CS2

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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