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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00081770 |
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.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Biological: peginterferon alfa-2b (SCH 54031) Drug: ribavirin (SCH 18908) Biological: peginterferon alfa-2a Drug: ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 2880 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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PegIntron 1.5 ug/kg/wk plus REBETOL: Experimental
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/wk in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
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Biological: peginterferon alfa-2b (SCH 54031)
1.5 ug/kg/wk SC for 48 weeks
Drug: ribavirin (SCH 18908)
weight based dose 800-1400 mg/day PO for 48 weeks
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PegIntron 1.0 ug/kg/wk plus REBETOL: Experimental
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/wk in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
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Biological: peginterferon alfa-2b (SCH 54031)
1.0 ug/kg/wk SC for 48 weeks
Drug: ribavirin (SCH 18908)
weight based dose 800-1400 mg/day PO for 48 weeks
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PEGASYS 180 ug/wk Plus COPEGUS: Active Comparator
PEGASYS (peginterferon alfa-2a) 180 ug/wk plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
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Biological: peginterferon alfa-2a
180 ug/wk SC administered for 48 weeks
Drug: ribavirin
1000-1200 mg/day PO for 48 weeks
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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
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Hematology laboratory results of:
Chemistry laboratory results of:
EXCLUSION CRITERIA:
Responsible Party: | Schering-Plough ( Janice Albrecht, PhD - Vice President, Global Clinical Research, Hepatology ) |
Study ID Numbers: | P03471, 2552898 |
Study First Received: | April 20, 2004 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00081770 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Interferon-alpha Anti-Infective Agents Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents |
Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2b Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents Liver Diseases Flaviviridae Infections Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Growth Inhibitors Hepatitis C |
Angiogenesis Modulating Agents RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2b Peginterferon alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |