ISIS 14803-CS2, Treatment With ISIS 14803, Administered IV in Patients With Chronic Hepatitis C Virus Infections
This study has been completed.
Information provided by:
Ionis Pharmaceuticals, Inc.
First received: May 6, 2002
Last updated: October 15, 2007
Last verified: October 2007
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.
Hepatitis C, Chronic
Drug: ISIS 14803
||Primary Purpose: Treatment
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035945
|Carlsbad, California, United States, 92008 |
Ionis Pharmaceuticals, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 6, 2002
||October 15, 2007
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 07, 2016
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections