Trial · NCT00081770

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

NCT00081770, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471). Trials, record NCT00081770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081770

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
NCT number: NCT00081770
Status: Completed
Phases: Phase 3
Enrollment: 4,469 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Hepatitis C, Chronic
Interventions: PegIntron (peginterferon alfa-2b; SCH 54031), PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908), PEGASYS (peginterferon alfa-2a), COPEGUS (ribavirin)
First posted: 2004-04-22
Last updated: 2017-04-04
Results first posted: 2009-10-30

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Sustained Virologic Response (SVR) Rate	Assessed at the end of a 24-week post-treatment follow-up	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	Mean Change From Baseline in the Log Viral Load at Treatment Week 4	Assessed at Baseline and 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.
Secondary	Virologic Response Rate at Treatment Week 12	Assessed at Treatment Week 12	Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12
Secondary	Mean Change From Baseline in the Log Viral Load at Treatment Week 2	Assessed at Baseline and 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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sustained Virologic Response (SVR) Rate	Assessed at the end of a 24-week post-treatment follow-up	Intent-to-Treat \[ITT\] Population defined as subjects who received at least one dose of study medication	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in the Log Viral Load at Treatment Week 4	Assessed at Baseline and Treatment Week 4	ITT Population defined as subjects who received at least one dose of study medication	Log10 IU/mL	MEAN
SECONDARY	Virologic Response Rate at Treatment Week 12	Assessed at Treatment Week 12	ITT Population defined as subjects who received at least one dose of study medication	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in the Log Viral Load at Treatment Week 2	Assessed at Baseline and Treatment Week 2	ITT Population defined as subjects who received at least one dose of study medication	Log10 IU/mL	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Sustained Virologic Response (SVR) Rate	PegIntron 1.5 ug/kg/wk Plus REBETOL	39.8		Percentage of participants
Sustained Virologic Response (SVR) Rate	PegIntron 1.0 ug/kg/wk Plus REBETOL	38.0		Percentage of participants
Sustained Virologic Response (SVR) Rate	PEGASYS 180 ug/wk Plus COPEGUS	40.9		Percentage of participants
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	PegIntron 1.5 ug/kg/wk Plus REBETOL	-2.32	Standard Deviation 1.50	Log10 IU/mL
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	PegIntron 1.0 ug/kg/wk Plus REBETOL	-2.02	Standard Deviation 1.42	Log10 IU/mL
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	PEGASYS 180 ug/wk Plus COPEGUS	-2.45	Standard Deviation 1.52	Log10 IU/mL
Virologic Response Rate at Treatment Week 12	PegIntron 1.5 ug/kg/wk Plus REBETOL	39.9		Percentage of participants
Virologic Response Rate at Treatment Week 12	PegIntron 1.0 ug/kg/wk Plus REBETOL	36.0		Percentage of participants
Virologic Response Rate at Treatment Week 12	PEGASYS 180 ug/wk Plus COPEGUS	45.0		Percentage of participants
Mean Change From Baseline in the Log Viral Load at Treatment Week 2	PegIntron 1.5 ug/kg/wk Plus REBETOL	-1.55	Standard Deviation 1.20	Log10 IU/mL

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PegIntron 1.5 ug/kg/wk Plus REBETOL	1,019
Overall Study	STARTED	PegIntron 1.0 ug/kg/wk Plus REBETOL	1,016
Overall Study	STARTED	PEGASYS 180 ug/wk Plus COPEGUS	1,035
Overall Study	COMPLETED	PegIntron 1.5 ug/kg/wk Plus REBETOL	517
Overall Study	COMPLETED	PegIntron 1.0 ug/kg/wk Plus REBETOL	470
Overall Study	COMPLETED	PEGASYS 180 ug/wk Plus COPEGUS	579
Overall Study	NOT COMPLETED	PegIntron 1.5 ug/kg/wk Plus REBETOL	502
Overall Study	NOT COMPLETED	PegIntron 1.0 ug/kg/wk Plus REBETOL	546
Overall Study	NOT COMPLETED	PEGASYS 180 ug/wk Plus COPEGUS	456

Source ClinicalTrials.gov

Adverse events1,002

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ANAEMIA	Blood and lymphatic system disorders	PegIntron 1.5 ug/kg/wk Plus REBETOL	344	1,019	555
other	ANAEMIA	Blood and lymphatic system disorders	PegIntron 1.0 ug/kg/wk Plus REBETOL	291	1,016	442
other	ANAEMIA	Blood and lymphatic system disorders	PEGASYS 180 ug/wk Plus COPEGUS	348	1,035	556
other	LEUKOPENIA	Blood and lymphatic system disorders	PegIntron 1.5 ug/kg/wk Plus REBETOL	95	1,019	153
other	LEUKOPENIA	Blood and lymphatic system disorders	PegIntron 1.0 ug/kg/wk Plus REBETOL	69	1,016	109
other	LEUKOPENIA	Blood and lymphatic system disorders	PEGASYS 180 ug/wk Plus COPEGUS	106	1,035	206
other	NEUTROPENIA	Blood and lymphatic system disorders	PegIntron 1.5 ug/kg/wk Plus REBETOL	263	1,019	466
other	NEUTROPENIA	Blood and lymphatic system disorders	PegIntron 1.0 ug/kg/wk Plus REBETOL	188	1,016	300
other	NEUTROPENIA	Blood and lymphatic system disorders	PEGASYS 180 ug/wk Plus COPEGUS	325	1,035	670
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	PegIntron 1.5 ug/kg/wk Plus REBETOL	29	1,019	38

1 to 10 of 1,002Source ClinicalTrials.gov

See all 1,002 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PegIntron 1.5 ug/kg/wk Plus REBETOL
Total, all-cause mortality	PegIntron 1.0 ug/kg/wk Plus REBETOL
Total, all-cause mortality	PEGASYS 180 ug/wk Plus COPEGUS
Total, other adverse events	PegIntron 1.5 ug/kg/wk Plus REBETOL	996	1,019
Total, other adverse events	PegIntron 1.0 ug/kg/wk Plus REBETOL	1,000	1,016
Total, other adverse events	PEGASYS 180 ug/wk Plus COPEGUS	1,018	1,035
Total, serious adverse events	PegIntron 1.5 ug/kg/wk Plus REBETOL	88	1,019
Total, serious adverse events	PegIntron 1.0 ug/kg/wk Plus REBETOL	94	1,016
Total, serious adverse events	PEGASYS 180 ug/wk Plus COPEGUS	121	1,035

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19625712	RESULT	PubMed
21488082	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00081770

GET https://conductscience.org/api/trials/v1/NCT00081770/events?page=2

API reference For AI assistants