Trial Outcomes & Findings for Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed) (NCT NCT00725842)

Results Overview

HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.

Recruitment status

TERMINATED

Target enrollment

97 participants

Primary outcome timeframe

24 weeks post end of treatment (EOT)

Results posted on

2015-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Peg-IFN Alfa-2b + Ribavirin Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Study STARTED	97
Overall Study Participants Eligible for Analysis	90
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Peg-IFN Alfa-2b + Ribavirin Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Study Lost to Follow-up	19
Overall Study Death	1
Overall Study Positive HCV-RNA at Visit 2	13
Overall Study Consent date prior to study start date	5
Overall Study Inclusion criterion not met	1
Overall Study No Visit 1 data	1

Baseline Characteristics

Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peg-IFN Alfa-2b + Ribavirin n=90 Participants Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Age, Continuous	46.0 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks post end of treatment (EOT)

Population: Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.

HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.

Outcome measures

Outcome measures
Measure	Peg-IFN Alfa-2b + Ribavirin n=90 Participants Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment	13 participants

SECONDARY outcome

Timeframe: 24 weeks post EOT

Population: The planned analysis for this outcome measure was not performed due to insufficient enrollment.

Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 24 weeks post EOT

Population: The planned analysis for this outcome measure was not performed due to insufficient enrollment.

Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 weeks post EOT

Population: 77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.

HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.

Outcome measures

Outcome measures
Measure	Peg-IFN Alfa-2b + Ribavirin n=77 Participants Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment	3 participants

Adverse Events

Peg-IFN Alfa-2b + Ribavirin

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peg-IFN Alfa-2b + Ribavirin n=96 participants at risk Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Endocrine disorders Hyperthyroidism	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
General disorders Death	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
General disorders Malaise	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Infections and infestations Staphylococcal sepsis	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Injury, poisoning and procedural complications Femoral neck fracture	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Injury, poisoning and procedural complications Road traffic accident	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Nervous system disorders Aphasia	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Nervous system disorders Cerebrovascular accident	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
Nervous system disorders Hemiplegia	1.0% 1/96 • Number of events 1 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.

Other adverse events

Other adverse events
Measure	Peg-IFN Alfa-2b + Ribavirin n=96 participants at risk Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Blood and lymphatic system disorders Anaemia	6.2% 6/96 • Number of events 6 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
General disorders Asthenia	15.6% 15/96 • Number of events 16 The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.

Additional Information

Senior Vice President,Global Clinical Development

Merck Sharp & Dohme

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study data disclosure is prohibited; data and study results are the exclusive property of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER