Trial · NCT01098097

Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)

NCT01098097, Completed, Merck Sharp & Dohme LLC; results first posted 2012-11-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011). Trials, record NCT01098097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01098097

On this page

Trial

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

Title: Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)
NCT number: NCT01098097
Status: Completed
Enrollment: 963 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Hepatitis C, Chronic
Interventions: Peginterferon alpha, Ribavirin
First posted: 2010-04-02
Last updated: 2014-11-26
Results first posted: 2012-11-20

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)	Up to 12 Weeks	An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.
Primary	Incidence of Thrombocytopenia	Up to 12 Weeks	Thrombocytopenia is a low blood platelet count
Primary	Incidence of Treatment Discontinuations Due to Adverse Events	Up to 12 Weeks	All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.
Primary	Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Up to 12 Weeks	All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS). The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)
Primary	Incidence of Dose Modifications Due to Adverse Events	Up to 12 Weeks	All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.
Secondary	Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)	Week 12	Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)	Up to 12 Weeks		percentage of participants	NUMBER
PRIMARY	Incidence of Thrombocytopenia	Up to 12 Weeks		percentage of participants	NUMBER
PRIMARY	Incidence of Treatment Discontinuations Due to Adverse Events	Up to 12 Weeks		percentage of participants	NUMBER
PRIMARY	Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Up to 12 Weeks		percentage of participants	NUMBER
PRIMARY	Incidence of Dose Modifications Due to Adverse Events	Up to 12 Weeks		percentage of participants	NUMBER
SECONDARY	Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)	Week 12	The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group25

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

Outcome	Group	Category	Value	Units
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)	Peginterferon Alpha and Ribavirin	Clinically significant adverse event	33.6	percentage of participants
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)	Peginterferon Alpha and Ribavirin	Serious adverse event	1.9	percentage of participants
Incidence of Thrombocytopenia	Peginterferon Alpha and Ribavirin		3.8	percentage of participants
Incidence of Treatment Discontinuations Due to Adverse Events	Peginterferon Alpha and Ribavirin	Treatment stopped - any AE	2.6	percentage of participants
Incidence of Treatment Discontinuations Due to Adverse Events	Peginterferon Alpha and Ribavirin	Dose reduced, then treatment stopped - any AE	0.1	percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Peginterferon Alpha and Ribavirin	TS - Anemia	0.6	percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Peginterferon Alpha and Ribavirin	TS - Leucopenia	0.2	percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Peginterferon Alpha and Ribavirin	TS - Neutropenia	0.2	percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Peginterferon Alpha and Ribavirin	TS - Thrombocytopenia	0.1	percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation	Peginterferon Alpha and Ribavirin	TS - Esophageal varices	0.0	percentage of participants

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Peginterferon Alpha and Ribavirin	963
Overall Study	COMPLETED	Peginterferon Alpha and Ribavirin	881
Overall Study	NOT COMPLETED	Peginterferon Alpha and Ribavirin	82

Source ClinicalTrials.gov

Adverse events23

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	Peginterferon Alpha and Ribavirin	104	963	106
other	Leucopenia	Blood and lymphatic system disorders	Peginterferon Alpha and Ribavirin	52	963	55
other	Neutropenia	Blood and lymphatic system disorders	Peginterferon Alpha and Ribavirin	55	963	59
other	Fatigue	General disorders	Peginterferon Alpha and Ribavirin	49	963	49
other	Pyrexia	General disorders	Peginterferon Alpha and Ribavirin	54	963	59
serious	Anemia	Blood and lymphatic system disorders	Peginterferon Alpha and Ribavirin	3	963	3
serious	Leucopenia	Blood and lymphatic system disorders	Peginterferon Alpha and Ribavirin	1	963	1
serious	Neutropenia	Blood and lymphatic system disorders	Peginterferon Alpha and Ribavirin	3	963	3
serious	Myocardial ischaemia	Cardiac disorders	Peginterferon Alpha and Ribavirin	1	963	1
serious	General physical health deterioration	General disorders	Peginterferon Alpha and Ribavirin	1	963	1

1 to 10 of 23Source ClinicalTrials.gov

See all 23 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Peginterferon Alpha and Ribavirin
Total, other adverse events	Peginterferon Alpha and Ribavirin	211	963
Total, serious adverse events	Peginterferon Alpha and Ribavirin	18	963

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.

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