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ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections Clinical research trials and ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections clinical trial. Human subjects often obtain the finest healthcare possible for their ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections  ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
For Condition: Hepatitis C, Chronic
Status: No longer recruiting
Sponsor(s): Isis Pharmaceuticals , Hepasense,Elan Pharmaceuticals
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Isis Pharmaceuticals
Carlsbad, California, 92008
United States
Additional Information:
Study ID Numbers: ISIS 14803-CS2;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035945
Other Hepatitis C, Chronic Studies:
1. IdB 1016 Treatment for Hepatitis C Disease
2. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
3. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
4. Evaluating Silymarin for Chronic Hepatitis C
5. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
Related Studies:
Other Hepatitis C, Chronic Clinical Trials
Other California Clinical Trials
Other Carlsbad Clinical Trials
ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
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