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Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. Clinical research trials and Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. clinical trial. Participants typically obtain the most effective healthcare available for their Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs. condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.  Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
For Condition: Hepatitis C, Chronic
Status: Recruiting
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria (partial list): - 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. - Prothrombin time and aPTT within normal reference range. - Serum bilirubin concentration within normal reference range. - Give written informed consent to participate in the study. Exclusion criteria (partial list): - 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. - 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
Total Enrollment: 22
Location and Contact Information:
Cornell Medical Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Nicole Taylor 212-746-2049
Memphis Gastroenterology Group *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Yvonne Shaw 901-747-3630
FutureCare Studies *Recruiting*
Springfield, Massachusetts, 01107
United States
Recruiting Kathryn Davis 413-788-1400
Birmingham Gastroenterology Associates *Recruiting*
Birmingham, Alabama, 35209
United States
Recruiting Sarah Ingle 205-271-8033
IMG Healthcare, LLC *Recruiting*
New Orleans, Louisiana, 70127
United States
Recruiting Colleen Grady 504-248-4146
Saint Louis University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Janice Strinko 314-977-9409
Community Clinical Trials *Recruiting*
Orange, California, 92868
United States
Recruiting Burton Ewing 714-628-8877
Nashville Medical Research Institute *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting Melanie Surber 615-383-1727
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Lee Sippel 248-551-1589
The Lynn Institute of the Rockies *Recruiting*
Colorado Springs, Colorado, 80909
United States
Recruiting Shelly Cobb 719-636-3784
Rochester Institute for Digestive Diseases and Sciences, Inc. *Recruiting*
Rochester, New York, 14607
United States
Recruiting Debbie Corcoran 585-399-7009
Duke Clinical Research Institute *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Lee Mallatratt 919-681-1674
Mayo Clinic Hospital *Recruiting*
Phoenix, Arizona, 85054
United States
Recruiting Alycia Metcalf 480-301-8260
Miami Research Associates, Inc. *Recruiting*
Miami, Florida, 33173
United States
Recruiting Margarita Mederos 305-279-0015
McGuire VAMC *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting Denice Shelton 804-675-5000
Blair Gastroenterology Associates *Recruiting*
Altoona, Pennsylvania, 16602
United States
Recruiting Joan Zhou 814-946-5469
Beth Israel Deconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Susanna Damitz 617-632-1073
Gastroenterology Center of the MidSouth, P.C. *Recruiting*
Germantown, Tennessee, 38138
United States
Recruiting Kathy Wilson 901-820-0090
Additional Information:
Study ID Numbers: ISIS 14803-CS3;
Study Start Date: May 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062816
Other Hepatitis C, Chronic Studies:
1. Evaluating Silymarin for Chronic Hepatitis C
2. ISIS 14803-CS2, Treatment with ISIS 14803, Administered IV in Patients with Chronic Hepatitis C Virus Infections
3. Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
4. IdB 1016 Treatment for Hepatitis C Disease
5. Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Related Studies:
Other Hepatitis C, Chronic Clinical Trials
Other Tennessee Clinical Trials
Other Germantown Clinical Trials
Addition of ISIS 14803 to therapy with peginterferon and ribavirin for chronic HCV patients not responding adequately to the two drugs.
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