Peg-Ifn Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: peginterferon alfa-2b (SCH 54031) (Biological); peginterferon alfa-2b (SCH 54031) (Biological); ribavirin (SCH 18908) (Drug); peginterferon alfa-2a (Biological); ribavirin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Schering-Plough Official(s) and/or principal investigator(s):
Stephanie S Noviello, MD, Study Director, Affiliation: Schering-Plough
Summary
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.
Clinical Details
Official title: Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of subjects with a sustained virologic response (SVR) at 24 weeks post-treatment. Co-primary treatment comparisons include: Arm 1 (PegIntron 1.5/R) vs Arm 2 (PegIntron 1.0/R), Arm 1 vs Arm 3 (PEGASYS/COPEGUS).
Secondary outcome: Comparison of SVR rates of Arm2 vs Arm 3; SVR for African Americans vs non-African Americans; SVR by baseline viral load; virologic response (VR) at end of treatment; VR at Treatment Week 24 (TW24); VR at TW12; relapse rate.
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: November 2007
Last updated: December 20, 2007
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