CompletedNCT00081770Updated Apr 4, 2017Results posted

Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)

A Phase 3 interventional study of PegIntron (peginterferon alfa-2b; SCH 54031) and PegIntron (peginterferon alfa-2b; SCH 54031) in Hepatitis C, Chronic, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 4,469
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Hepatitis C, Chronic

Browse trials for

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 4,469 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 4,469 participants (actual)

Study arms

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
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
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
Biological: PEGASYS (peginterferon alfa-2a) · Drug: COPEGUS (ribavirin)

Interventions

BiologicalPegIntron (peginterferon alfa-2b; SCH 54031)
1.5 ug/kg/week subcutaneously (SC) for 48 weeks
Also known as: PegIntron
BiologicalPegIntron (peginterferon alfa-2b; SCH 54031)
1.0 ug/kg/week SC for 48 weeks
Also known as: PegIntron
DrugREBETOL (ribavirin; SCH 18908)
weight based dose 800-1400 mg/day orally (PO) for 48 weeks
Also known as: REBETOL [the Schering-Plough brand name for ribavirin]
BiologicalPEGASYS (peginterferon alfa-2a)
180 ug/week SC administered for 48 weeks
Also known as: PEGASYS
DrugCOPEGUS (ribavirin)
1000-1200 mg/day PO for 48 weeks
Also known as: COPEGUS [the Hoffman-La Roche brand name for ribavirin]

What researchers measure

Primary outcomes

Sustained Virologic Response (SVR) Rate
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.
Time frame: Assessed at the end of a 24-week post-treatment follow-up

Secondary outcomes

Mean Change From Baseline in the Log Viral Load at Treatment Week 4
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.
Time frame: Assessed at Baseline and Treatment Week 4
Virologic Response Rate at Treatment Week 12
Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12
Time frame: Assessed at Treatment Week 12
Mean Change From Baseline in the Log Viral Load at Treatment Week 2
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.
Time frame: Assessed at Baseline and Treatment Week 2

Results

Posted Oct 30, 2009

Participant flow

Participant flow — Overall Study
Milestone	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Started	1019	1016	1035
Completed	517	470	579
Not completed	502	546	456
Withdrew: Adverse event	130	98	136
Withdrew: Lack of efficacy	262	357	211
Withdrew: Lost to follow-up	45	34	45
Withdrew: Protocol violation	15	10	10
Withdrew: Withdrawal by subject	45	40	42
Withdrew: Did not meet protocol eligibility	2	0	3
Withdrew: Administrative	1	0	1
Withdrew: Other	2	7	8

Outcome measures

PrimarySustained Virologic Response (SVR) Rate

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.

Time frame:: Assessed at the end of a 24-week post-treatment follow-up
Reported as:: Number · Percentage of participants

Sustained Virologic Response (SVR) Rate
Percentage of participants	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Sustained Virologic Response (SVR) Rate	39.8	38.0	40.9

Statistical analysis

PegIntron 1.5 ug/kg/wk Plus REBETOL vs PEGASYS 180 ug/wk Plus COPEGUS · Regression, Logistic · p = 0.567 (Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.) · Odds ratio (or): 0.95 · 95% CI 0.79 to 1.14The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).
PegIntron 1.5 ug/kg/wk Plus REBETOL vs PegIntron 1.0 ug/kg/wk Plus REBETOL · Regression, Logistic · p = 0.195 (Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.) · Odds ratio (or): 1.08 · 95% CI 0.90 to 1.30The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).

SecondaryMean Change From Baseline in the Log Viral Load at Treatment Week 4

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.

Time frame:: Assessed at Baseline and Treatment Week 4
Reported as:: Mean · Log10 IU/mL

Mean Change From Baseline in the Log Viral Load at Treatment Week 4
Log10 IU/mL	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	-2.32 ± 1.50	-2.02 ± 1.42	-2.45 ± 1.52

SecondaryVirologic Response Rate at Treatment Week 12

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

Time frame:: Assessed at Treatment Week 12
Reported as:: Number · Percentage of participants

Virologic Response Rate at Treatment Week 12
Percentage of participants	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Virologic Response Rate at Treatment Week 12	39.9	36.0	45.0

Statistical analysis

PegIntron 1.5 ug/kg/wk Plus REBETOL · Percentage of participants: 39.9 · 95% CI 36.9 to 42.9Percentage of participants with undetectable HCV-RNA at Treatment Week 12
PegIntron 1.0 ug/kg/wk Plus REBETOL · Percentage of participants: 36.0 · 95% CI 33.1 to 39.0Percentage of participants with undetectable HCV-RNA at Treatment Week 12
PEGASYS 180 ug/wk Plus COPEGUS · Percentage of participants: 45.0 · 95% CI 42.0 to 48.1Percentage of participants with undetectable HCV-RNA at Treatment Week 12

SecondaryMean Change From Baseline in the Log Viral Load at Treatment Week 2

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.

Time frame:: Assessed at Baseline and Treatment Week 2
Reported as:: Mean · Log10 IU/mL

Mean Change From Baseline in the Log Viral Load at Treatment Week 2
Log10 IU/mL	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
Mean Change From Baseline in the Log Viral Load at Treatment Week 2	-1.55 ± 1.20	-1.30 ± 1.12	-1.60 ± 1.24

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PegIntron 1.5 ug/kg/wk Plus REBETOL	—	88/1,019 (8.6%)	996/1,019 (97.7%)
PegIntron 1.0 ug/kg/wk Plus REBETOL	—	94/1,016 (9.3%)	1,000/1,016 (98.4%)
PEGASYS 180 ug/wk Plus COPEGUS	—	121/1,035 (11.7%)	1,018/1,035 (98.4%)

Most frequent serious events

Showing 10 of 286

Most frequent serious events
Event	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
SUICIDAL IDEATIONPsychiatric disorders	13/1019	8/1016	5/1035
CHEST PAINGeneral disorders	8/1019	8/1016	8/1035
CELLULITISInfections and infestations	2/1019	5/1016	6/1035
PNEUMONIAInfections and infestations	2/1019	3/1016	6/1035
DYSPNOEARespiratory, thoracic and mediastinal disorders	2/1019	5/1016	3/1035
CHOLELITHIASISHepatobiliary disorders	5/1019	3/1016	3/1035
DEPRESSIONPsychiatric disorders	5/1019	3/1016	3/1035
NAUSEAGastrointestinal disorders	0/1019	1/1016	5/1035
ABDOMINAL PAINGastrointestinal disorders	2/1019	4/1016	4/1035
APPENDICITISInfections and infestations	2/1019	4/1016	4/1035

Most frequent other events

Showing 10 of 48

Most frequent other events
Event	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS
FATIGUEGeneral disorders	672/1019	676/1016	656/1035
HEADACHENervous system disorders	508/1019	486/1016	438/1035
NAUSEAGastrointestinal disorders	433/1019	377/1016	375/1035
INSOMNIAPsychiatric disorders	401/1019	389/1016	428/1035
CHILLSGeneral disorders	397/1019	365/1016	243/1035
PYREXIAGeneral disorders	356/1019	331/1016	237/1035
ANAEMIABlood and lymphatic system disorders	344/1019	291/1016	348/1035
NEUTROPENIABlood and lymphatic system disorders	263/1019	188/1016	325/1035
RASHSkin and subcutaneous tissue disorders	225/1019	223/1016	290/1035
MYALGIAMusculoskeletal and connective tissue disorders	274/1019	270/1016	233/1035

Baseline characteristics

Age, Continuous
Age, Continuous(years)	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS	Total
Mean	47.5 ± 7.8	47.5 ± 8.1	47.6 ± 8.2	47.5 ± 8.0

Sex: Female, Male
Sex: Female, Male(Participants)	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron 1.0 ug/kg/wk Plus REBETOL	PEGASYS 180 ug/wk Plus COPEGUS	Total
Female	406	409	422	1237
Male	613	607	613	1833

Study locations

No study locations are listed for this record.

References and documents

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. doi: 10.1056/NEJMoa0808010. Epub 2009 Jul 22. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027. PubMed 19625712 ↗
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. doi: 10.1002/hep.24358. PubMed 21488082 ↗

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00081770
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 22, 2004
Start date: Mar 2004
Primary completion: Nov 2007
Completion: Nov 2007
Results posted: Oct 30, 2009
Last update: Apr 4, 2017

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion