Completed

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

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What is being tested

PegIntron (peginterferon alfa-2b; SCH 54031)

+ REBETOL (ribavirin; SCH 18908)
+ PEGASYS (peginterferon alfa-2a)
Biological
Drug
Who is being recruted

Blood-Borne Infections
+16

+ Chronic Disease
+ Communicable Diseases
From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleComparison 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 
NCT00081770
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
4469 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood-Borne Infections
Chronic Disease
Communicable Diseases
Digestive System Diseases
Enterovirus Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Infections
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Flaviviridae Infections
Hepatitis C, Chronic
Disease Attributes
Criteria

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 epoetin \[EPO\], 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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

1.5 ug/kg/week subcutaneously (SC) for 48 weeks

weight based dose 800-1400 mg/day orally (PO) for 48 weeks
Group II
Experimental
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

1.5 ug/kg/week subcutaneously (SC) for 48 weeks

weight based dose 800-1400 mg/day orally (PO) for 48 weeks
Group III
Active Comparator
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

180 ug/week SC administered for 48 weeks

1000-1200 mg/day PO for 48 weeks
Study Objectives
Primary Objectives

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.
Secondary Objectives

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.

Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers