Trial Outcomes & Findings for Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011) (NCT NCT01098097)

Last Updated: 2014-11-26

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

963 participants

Primary outcome timeframe

Up to 12 Weeks

Results posted on

2014-11-26

Participant Flow

First participant enrolled: 9 February 2009; last participant completed: 17 October 2011. The study was conducted in 117 centers in 12 countries.

Participant milestones

Participant milestones
Measure	Peginterferon Alpha and Ribavirin Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Overall Study STARTED	963
Overall Study COMPLETED	881
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alpha and Ribavirin Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Overall Study Adverse Event	17
Overall Study Lost to Follow-up	18
Overall Study Status unknown	16
Overall Study No reason reported	31

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	420 Participants n=5 Participants
Sex: Female, Male Male	543 Participants n=5 Participants
Previous non-response type Null responder	346 participants n=5 Participants
Previous non-response type Virologic breakthrough	67 participants n=5 Participants
Previous non-response type Relapse	544 participants n=5 Participants
Previous non-response type Previous non-response type not known	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 Weeks

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) Clinically significant adverse event	33.6 percentage of participants
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) Serious adverse event	1.9 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 Weeks

Thrombocytopenia is a low blood platelet count

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Incidence of Thrombocytopenia	3.8 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 Weeks

All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Incidence of Treatment Discontinuations Due to Adverse Events Treatment stopped - any AE	2.6 percentage of participants
Incidence of Treatment Discontinuations Due to Adverse Events Dose reduced, then treatment stopped - any AE	0.1 percentage of participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Anemia	0.6 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Leucopenia	0.2 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Neutropenia	0.2 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Thrombocytopenia	0.1 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Esophageal varices	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Splenomegaly	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS -Portal hypertensive gastropathy	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation TS - Hepatomegaly	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Anemia	0.1 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Leucopenia	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Neutropenia	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Thrombocytopenia	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Esophageal varices	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Splenomegaly	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Portal hypertensive gastropathy	0.0 percentage of participants
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation DR/TS - Hepatomegaly	0.0 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 Weeks

All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=963 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Incidence of Dose Modifications Due to Adverse Events Dose Reduced	9.7 percentage of participants
Incidence of Dose Modifications Due to Adverse Events Dose Reduced, then Treatment Stopped	0.1 percentage of participants
Incidence of Dose Modifications Due to Adverse Events Dose Reduced, Treatment Suspended and Restarted	0.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit

Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.

Outcome measures

Outcome measures
Measure	Peginterferon Alpha and Ribavirin n=920 Participants Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)	42.4 percentage of participants Interval 39.1 to 45.9

Adverse Events

Peginterferon Alpha and Ribavirin

Serious events: 18 serious events

Other events: 211 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peginterferon Alpha and Ribavirin n=963 participants at risk Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Blood and lymphatic system disorders Anemia	0.31% 3/963 • Number of events 3
Blood and lymphatic system disorders Leucopenia	0.10% 1/963 • Number of events 1
Blood and lymphatic system disorders Neutropenia	0.31% 3/963 • Number of events 3
Cardiac disorders Myocardial ischaemia	0.10% 1/963 • Number of events 1
General disorders General physical health deterioration	0.10% 1/963 • Number of events 1
General disorders Pyrexia	0.10% 1/963 • Number of events 1
Infections and infestations Acute tonsillitis	0.10% 1/963 • Number of events 1
Infections and infestations Campylobacter infection	0.10% 1/963 • Number of events 1
Infections and infestations Erysipelas	0.10% 1/963 • Number of events 1
Infections and infestations Gastroenteritis	0.10% 1/963 • Number of events 1
Nervous system disorders Loss of consciousness	0.10% 1/963 • Number of events 1
Nervous system disorders Parkinson's disease	0.10% 1/963 • Number of events 1
Nervous system disorders Sciatica	0.10% 1/963 • Number of events 1
Nervous system disorders Transient ischaemic attack	0.10% 1/963 • Number of events 1
Psychiatric disorders Anxiety	0.10% 1/963 • Number of events 1
Psychiatric disorders Depression	0.21% 2/963 • Number of events 2
Renal and urinary disorders Nephrolithiasis	0.10% 1/963 • Number of events 1
Reproductive system and breast disorders Metrorrhagia	0.10% 1/963 • Number of events 1

Other adverse events

Other adverse events
Measure	Peginterferon Alpha and Ribavirin n=963 participants at risk Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Blood and lymphatic system disorders Anaemia	10.8% 104/963 • Number of events 106
Blood and lymphatic system disorders Leucopenia	5.4% 52/963 • Number of events 55
Blood and lymphatic system disorders Neutropenia	5.7% 55/963 • Number of events 59
General disorders Fatigue	5.1% 49/963 • Number of events 49
General disorders Pyrexia	5.6% 54/963 • Number of events 59

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts. Investigator agrees to meet with sponsor's representatives prior to submission for publication to discuss and resolve any disagreements.
Publication restrictions are in place

Restriction type: OTHER