Hepatitis C, ChronicPhase 1/2NCT00062816
Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
A Phase 1/2 study testing ISIS 14803, peginterferon alfa, ribavirin in people with Hepatitis C, Chronic, run by Ionis Pharmaceuticals, Inc. at 25 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- ISIS 14803, peginterferon alfa, ribavirin
- How many people
- 22 participants
- Where
- 25 sitesUnited States
- Study dates
- Jun 2003to Jan 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Prothrombin time and aPTT within normal reference range.
- Serum bilirubin concentration within normal reference range.
- Give written informed consent to participate in the study.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Blair Gastroenterology Associates
Altoona, Pennsylvania, 16602
Northwest Gastroenterolgy Assoc.
Bellevue, Washington, 98004
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209
Idaho Gastroenterology Assoc.
Boise, Idaho, 83702
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215
Consultants for Clinical Research
Cincinnati, Ohio, 45219
The Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Duke Clinical Research Institute
Durham, North Carolina, 27705
Gastroenterology Center of the MidSouth, P.C.
Germantown, Tennessee, 38138
Baylor College of Medicine-VAMC
Houston, Texas, 77030
University of Florida
Jacksonville, Florida, 32209
Memphis Gastroenterology Group
Memphis, Tennessee, 38120
Miami Research Associates, Inc.
Miami, Florida, 33173
Nashville Medical Research Institute
Nashville, Tennessee, 37205
IMG Healthcare, LLC
New Orleans, Louisiana, 70127
Cornell Medical Center
New York, New York, 10021
Community Clinical Trials
Orange, California, 92868
Mayo Clinic Hospital
Phoenix, Arizona, 85054
McGuire VAMC
Richmond, Virginia, 23249
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, 14607
William Beaumont Hospital
Royal Oak, Michigan, 48073
Spokane Digestive Disease Center
Spokane, Washington, 99207
FutureCare Studies
Springfield, Massachusetts, 01107
Saint Louis University
St Louis, Missouri, 63110
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033
About this study
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.
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- ISIS 14803, peginterferon alfa, ribavirin
- Keywords
- Hepatitis, Chronic
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 14803, peginterferon alfa, ribavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2003 (estimated)
- Study startJun 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062816
- Sponsor's protocol ID
- ISIS 14803-CS3
- Status last verified
- Oct 2007
- First submitted
- 16 Jun 2003
- Last updated
- 5 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
- ClinicalTrials.gov ID
- NCT00062816
- Acronym / sponsor ID
- ISIS 14803-CS3
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004
- First posted
- 18 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIS 14803, peginterferon alfa, ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ISIS 14803, peginterferon alfa, ribavirin in people with Hepatitis C, Chronic, run by Ionis Pharmaceuticals, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.