Trial Outcomes & Findings for Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243) (NCT NCT00709059)

Results Overview

VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond.

Recruitment status

COMPLETED

Target enrollment

538 participants

Primary outcome timeframe

Treatment Week 72

Results posted on

2015-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	PegIntron Plus Rebetol Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
Overall Study STARTED	538
Overall Study COMPLETED	444
Overall Study NOT COMPLETED	94

Reasons for withdrawal

Reasons for withdrawal
Measure	PegIntron Plus Rebetol Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
Overall Study Lost to Follow-up	34
Overall Study Withdrawal by Subject	19
Overall Study Physician Decision	7
Overall Study Disease complication	3
Overall Study Side effects	20
Overall Study Serious side effects	11

Baseline Characteristics

Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PegIntron Plus Rebetol n=538 Participants Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
Age, Customized <50 years	301 Participants n=5 Participants
Age, Customized >=50 years	204 Participants n=5 Participants
Age, Customized age not available	33 Participants n=5 Participants
Sex/Gender, Customized Female	203 Participants n=5 Participants
Sex/Gender, Customized Male	302 Participants n=5 Participants
Sex/Gender, Customized Gender not available	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment Week 72

Population: Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.

VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond.

Outcome measures

Outcome measures
Measure	PegIntron Plus Rebetol n=505 Participants Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
Number of Study Participants Who Had a Virological Response (VR) at Week-72	176 Participants

Adverse Events

PegIntron Plus Rebetol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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 participating physician (PP) agrees not to publish/present any interim results of the Survey without prior written consent of Schering- Plough (SP). The PP further agrees to provide 30 days written notice to SP prior to submission for publication or presentation to permit SP to review and comment on any presentation, which right shall include editorial rights. If the parties disagree, the PP agrees to meet with SP to discuss and resolve any such issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER