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Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 Clinical research trials and Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1. Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 clinical trial. Test subjects typically receive the most effective healthcare possible for their Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1  Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1
Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1
For Condition: Chronic Hepatitis C
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PEG-Intron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Details: PEG-Intron Dose: Screening 2 Weight 40-50 kg Volume to Inject (mL)0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL)0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL)0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL)0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL)0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL)0.58 from two vials REBETOL Dosage (for Use With PEG-INTRON): Screening 2 Weight 40-60 kg Daily Dose 800mg; Screening 2 Weight >65-85 kg Daily Dose 1000mg; Screening 2 Weight >85-105 kg Daily Dose 1200mg; Screening 2 Weight >105-125 kg Daily Dose 1400mg The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week COPEGUS Dosage (for Use With PEGASYS): Screening 2 Weight <75kg Daily Dose 1000mg; Screening 2 Weight > or = 75kg Daily Dose 1200mg NOTE: Double Blind for PEG-Intron; Open Label for REBETOL, PEGASYS and COPEGUS
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Previously untreated adults with chronic hepatitis C (HCV RNA qPCR plasma positive) - Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) - Compensated liver disease - No significant co-existing psychiatric disease - Historic liver biopsy slides available - Adults aged 18-70 - Individuals weighing 88-275 pounds (40-125 kg) - Free from substance abuse for past 2 years - Those suffering from diabetes and/or hypertension must have normal eye exams and retinal photographs (these will be done as part of the study before hepatitis C treatment is given) - Patients and partners of patients willing to use adequate contraception during the course of the study - Hematology laboratory results of: * Hemoglobin (HGB) > 12 g/dL for females or > 13g/dL for males * White Blood Cell Count (WBC) > 3,000 mm3 * Neutrophils > 1,500 mm3 * Platelets > 80,000 mm3 - Chemistry laboratory results of: * Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin * Antinuclear antibody (ANA) < 1:320 * Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, HbA1C must be < 8.5 EXCLUSION CRITERIA: - Previous hepatitis C treatment - Pregnant women or partners of pregnant women - Patients or partners of patients who intend to become pregnant any time during the 48 weeks - Women who are breast feeding - People with liver disease not caused by hepatitis C - Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV) - Patients with a history of liver cancer (hepatocellular carcinoma) - Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency - Body organ transplant - Any known or suspected cancer within the past 5 years - Individuals who currently use EPO, G-CSF and/or GM-CSF - Those having a history of or active clinical gout - People who have chronic pulmonary disease - Individuals who have a medical condition that would likely require systemic steroids - Those with a history of central nervous system (CNS trauma) or seizure disorders - Current or previous use of lithium or antipsychotic drugs - Individuals who currently have or show signs of moderate to severe depression - Patients with clinically significant electrocardiogram (ECG) abnormalities - Individuals with serious heart problems such as those who have had a heart attack, high blood pressure, or other heart problems - Patients that weigh > 231-275 pounds (105-125 kg) AND have a body mass index (BMI) > 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age < 55 for male relatives or < 65 for female relatives (b) People with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking
Total Enrollment: 2880
Location and Contact Information:
VA Medical Center *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Allan Weston 816-861-4700
Dean Medical Center *Recruiting*
Madison, Wisconsin, 53715
United States
Recruiting James Levin 608-252-8020
Duke University Medical School *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting John McHutchison 919-668-7177
Regional Gastroenterology Associates of Lancaster *Recruiting*
Lancaster, Pennsylvania, 17603
United States
Recruiting Alexandra Gibas 717-544-3400
Additional Information:
Study ID Numbers: P03471; 2552898
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081770
Other Chronic Hepatitis C Studies:
1. Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus with Standard Treatment
2. Pegasys in Combination with Copegus in Previously Untreated Patients with Chronic Hepatitis C Genotype 1 of High Viral Count and Body Weight > 85 kg (187 lbs)
3. Peg-Intron for Prevention of Disease Progression in Chronic Hepatitis C Patients with Cirrhosis who failed with a Interferon plus Ribavirin Therapy
4. Long-Term Therapy with Ribavirin for Chronic Hepatitis C
5. Pegasys in Combination with Copegus in Previously Untreated Patients with Chronic Hepatitis C Virus Genotype 2 or 3
Related Studies:
Other Chronic Hepatitis C Clinical Trials
Other Pennsylvania Clinical Trials
Other Lancaster Clinical Trials
Pegylated-Interferon Dose Evaluations for Previously Untreated Subjects with Chronic Hepatitis C (CHC) Infected with Genotype 1
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