Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00081770

First received: April 20, 2004

Last updated: April 4, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 20, 2004
Last Updated Date	April 4, 2011
Start Date ^ICMJE	March 2004
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2011)	Sustained Virologic Response (SVR) Rate [ Time Frame: Assessed at the end of a 24-week post-treatment follow-up ] [ Designated as safety issue: No ] SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
Original Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	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). [ Time Frame: 48-week treatment; 24-week follow-up ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00081770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2011)	Mean Change From Baseline in the Log Viral Load at Treatment Week 4 [ Time Frame: Assessed at Baseline and Treatment Week 4 ] [ Designated as safety issue: No ] The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group. Virologic Response Rate at Treatment Week 12 [ Time Frame: Assessed at Treatment Week 12 ] [ Designated as safety issue: No ] Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12 Mean Change From Baseline in the Log Viral Load at Treatment Week 2 [ Time Frame: Assessed at Baseline and Treatment Week 2 ] [ Designated as safety issue: No ] The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.
Original Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	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. [ Time Frame: 48-week treatment; 24-week follow-up ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED)
Official Title ^ICMJE	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
Brief 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) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 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.
Detailed Description	PegIntron Dose will be administered once weekly subcutaneously on the same day of the week: 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 PegIntron): Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight >65-85 kg Daily Dose 1000 mg; Screening 2 Weight >85-105 kg Daily Dose 1200 mg; Screening 2 Weight >105-125 kg Daily Dose 1400 mg 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 <75 kg Daily Dose 1000 mg; Screening 2 Weight > or = 75 kg Daily Dose 1200mg NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La Roche brand name for ribavirin.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis C, Chronic
Intervention ^ICMJE	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week subcutaneously (SC) for 48 weeks Other Name: PegIntron Biological: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week SC for 48 weeks Other Name: PegIntron Drug: REBETOL (ribavirin; SCH 18908) weight based dose 800-1400 mg/day orally (PO) for 48 weeks Other Name: REBETOL [the Schering-Plough brand name for ribavirin] Biological: PEGASYS (peginterferon alfa-2a) 180 ug/week SC administered for 48 weeks Other Name: PEGASYS Drug: COPEGUS (ribavirin) 1000-1200 mg/day PO for 48 weeks Other Name: COPEGUS [the Hoffman-La Roche brand name for ribavirin]
Study Arm (s)	Experimental: PegIntron 1.5 ug/kg/wk plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908) Experimental: PegIntron 1.0 ug/kg/wk plus REBETOL PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908) Active Comparator: PEGASYS 180 ug/wk Plus COPEGUS PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up Interventions: Biological: PEGASYS (peginterferon alfa-2a) Drug: COPEGUS (ribavirin)
Publications *	McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. Epub 2009 Jul 22. Melia MT, Muir AJ, McCone J, Shiffman ML, King JW, Herrine SK, Galler GW, Bloomer JR, Nunes FA, Brown KA, Mullen KD, Ravendhran N, Ghalib RH, Boparai N, Jiang R, Noviello S, Brass CA, Albrecht JK, McHutchison JG, Sulkowski MS; IDEAL Study Team. Racial differences in hepatitis C treatment eligibility. Hepatology. 2011 Jul;54(1):70-8.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	4469
Completion Date	November 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA: Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid [HCV RNA] quantitative polymerase chain reaction [qPCR] plasma positive) Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) Compensated liver disease Pretreatment 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/mm^3 Neutrophils ≥ 1,500/mm^3 Platelets ≥ 80,000/mm^3 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, glycosylated hemoglobin [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 breastfeeding Individuals 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 glucose-6-phosphate dehydrogenase [G6PD] deficiency Body organ transplant Any known or suspected cancer within the past 5 years Individuals who currently use epoietin [EPO], granulocyte colony stimulating factor [G-CSF] and/or granulocyte monocyte colony stimulating factor [GM-CSF] Those having a history of or active clinical gout Individuals 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 or history of significant psychiatric disorders Patients with clinically significant electrocardiogram (ECG) abnormalities Individuals with serious heart problems such as those who have had a heart attack, uncontrolled 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) Individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00081770
Other Study ID Numbers ^ICMJE	P03471, 2552898
Has Data Monitoring Committee	Yes
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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