Trial Outcomes & Findings for Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED) (NCT NCT00423800)

NCT ID: NCT00423800

Last Updated: 2017-04-07

Results Overview

Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA. Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 56 participants
• Primary outcome timeframe: 24 weeks following completion of 24 or 48 weeks of therapy
• Results posted on: 2017-04-07

Participant Flow

56 participants were enrolled. 51 participants were screening failures, were not randomized and are not included in the study. Of the 5 participants randomized, 2 did not meet inclusion/exclusion criteria. All 5 are included in the intent-to-treat (ITT) population.

Participant milestones

Measure	Pegetron® - 24 Weeks Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment	Pegetron® - 48 Weeks Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Overall Study STARTED	3	2
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Pegetron® - 24 Weeks Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment	Pegetron® - 48 Weeks Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Overall Study Protocol Violation	0	1

Baseline Characteristics

Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)

Baseline characteristics by cohort

Measure	Pegetron® - 24 Weeks n=3 Participants Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment	Pegetron® - 48 Weeks n=2 Participants Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment	Total n=5 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	22 years STANDARD_DEVIATION 0 • n=7 Participants	41.2 years STANDARD_DEVIATION 18.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.

Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.

Outcome measures

Measure	Pegetron® - 24 Weeks n=3 Participants Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment	Pegetron® - 48 Weeks n=2 Participants Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Number of Participants With a Sustained Virologic Response Responders	3 Participants	1 Participants
Number of Participants With a Sustained Virologic Response Non-responders	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 weeks following completion of 24 or 48 weeks of therapy

Population: ITT population that completed the study.

Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).

Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment.

Outcome measures

Measure	Pegetron® - 24 Weeks n=3 Participants Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment	Pegetron® - 48 Weeks n=1 Participants Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Number of Participants With a Virological Relapse Participants with Virological Relapse	0 Participants	0 Participants
Number of Participants With a Virological Relapse Participants with No Virological Relapse	3 Participants	1 Participants

Adverse Events

Screen Failures

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Pegetron® - 24 Weeks

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Pegetron® - 48 Weeks

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Screen Failures n=2 participants at risk Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.	Pegetron® - 24 Weeks n=3 participants at risk Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.	Pegetron® - 48 Weeks n=2 participants at risk Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
Infections and infestations GROIN ABSCESS	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Metabolism and nutrition disorders HYPOGLYCAEMIC SEIZURE	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).

Other adverse events

Measure	Screen Failures n=2 participants at risk Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.	Pegetron® - 24 Weeks n=3 participants at risk Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.	Pegetron® - 48 Weeks n=2 participants at risk Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
Eye disorders EYE IRRITATION	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Eye disorders VISION BLURRED	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Gastrointestinal disorders NAUSEA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
General disorders CHILLS	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
General disorders FATIGUE	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	66.7% 2/3 • Number of events 3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
General disorders IRRITABILITY	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
General disorders PYREXIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	66.7% 2/3 • Number of events 4 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Nervous system disorders DIZZINESS	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Nervous system disorders DYSGEUSIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Nervous system disorders HYPOAESTHESIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Psychiatric disorders AFFECT LABILITY	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Psychiatric disorders INSOMNIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/3 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	50.0% 1/2 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
Skin and subcutaneous tissue disorders RASH	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	33.3% 1/3 • Number of events 1 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).	0.00% 0/2 Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review.
• Publication restrictions are in place

Restriction type: OTHER