Hepatitis C, ChronicPhase 2NCT00035945
ISIS 14803-CS2, Treatment With ISIS 14803, Administered IV in Patients With Chronic Hepatitis C Virus Infections
A Phase 2 study testing ISIS 14803 in people with Hepatitis C, Chronic, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- ISIS 14803
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2001to 1 May 2004
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- ISIS 14803
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 14803Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2002 (estimated)
- Study start1 Oct 2001
- Primary completion1 May 2004
- Study completion1 May 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hepasense, Elan Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035945
- Sponsor's protocol ID
- ISIS 14803-CS2
- Status last verified
- Oct 2007
- First submitted
- 6 May 2002
- 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
- ISIS 14803-CS2, Treatment With ISIS 14803, Administered IV in Patients With Chronic Hepatitis C Virus Infections
- ClinicalTrials.gov ID
- NCT00035945
- Acronym / sponsor ID
- ISIS 14803-CS2
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hepasense, Elan Pharmaceuticals
- Study start
- 1 Oct 2001 (actual)
- Primary completion
- 1 May 2004 (actual)
- Study completion
- 1 May 2004 (actual)
- First posted
- 8 May 2002 (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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- 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.
Key exclusion criteria (17 listed)
- 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.
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 | 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS 14803 in people with Hepatitis C, Chronic, run by Ionis Pharmaceuticals, Inc. at 1 site 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 20 inclusion and 17 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 1 site 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 phase mean?
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.