Trial · NCT00723931

PegIntron Injection Surveillance Plan (Study P04123)

NCT00723931, Completed, Merck Sharp & Dohme LLC; results first posted 2010-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PegIntron Injection Surveillance Plan (Study P04123). Trials, record NCT00723931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723931

On this page

Trial

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

Title: PegIntron Injection Surveillance Plan (Study P04123)
NCT number: NCT00723931
Status: Completed
Enrollment: 1,267 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Hepatitis C, Chronic
Interventions: Peginterferon alfa-2b (SCH 54031)
First posted: 2008-07-29
Last updated: 2015-11-04
Results first posted: 2010-12-13

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants That Reported a Serious Adverse Event	24 weeks after administration of PegIntron Injection	Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.
Primary	Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold	24 weeks after administration of PegIntron Injection.	Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants That Reported a Serious Adverse Event	24 weeks after administration of PegIntron Injection		Participants	NUMBER
PRIMARY	Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold	24 weeks after administration of PegIntron Injection.		Participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants That Reported a Serious Adverse Event	Pegintron/Pegintron Redipen Injection		15		Participants
Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold	Pegintron/Pegintron Redipen Injection		820		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pegintron/Pegintron Redipen Injection	1,267
Overall Study	COMPLETED	Pegintron/Pegintron Redipen Injection	1,267
Overall Study	NOT COMPLETED	Pegintron/Pegintron Redipen Injection	0

Source ClinicalTrials.gov

Adverse events38

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/Pegintron Redipen Injection	237	1,267	243
other	Leukopenia	Blood and lymphatic system disorders	Pegintron/Pegintron Redipen Injection	144	1,267	152
other	Thrombocytopenia	Blood and lymphatic system disorders	Pegintron/Pegintron Redipen Injection	81	1,267	84
other	Dyspepsia	Gastrointestinal disorders	Pegintron/Pegintron Redipen Injection	102	1,267	112
other	Nausea	Gastrointestinal disorders	Pegintron/Pegintron Redipen Injection	69	1,267	76
other	Asthenia	General disorders	Pegintron/Pegintron Redipen Injection	80	1,267	87
other	Fatigue	General disorders	Pegintron/Pegintron Redipen Injection	70	1,267	76
other	Pyrexia	General disorders	Pegintron/Pegintron Redipen Injection	71	1,267	86
other	White Blood Cell Count Decreased	Investigations	Pegintron/Pegintron Redipen Injection	97	1,267	107
other	Decreased Appetite	Metabolism and nutrition disorders	Pegintron/Pegintron Redipen Injection	124	1,267	137

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pegintron/Pegintron Redipen Injection
Total, other adverse events	Pegintron/Pegintron Redipen Injection	820	1,267
Total, serious adverse events	Pegintron/Pegintron Redipen Injection	15	1,267

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT00723931

GET https://conductscience.org/api/trials/v1/NCT00723931/events?page=2

API reference For AI assistants