Trial · NCT03537274

Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)

NCT03537274, Phase 2, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016). Trials, record NCT03537274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03537274

On this page

Trial

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

Title: Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
NCT number: NCT03537274
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,224 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Hepatitis C
Interventions: PEG-Intron, Interferon Alfa-2B
First posted: 2018-05-25
Last updated: 2019-04-09
Results first posted: 2019-04-09
Limitations and caveats: Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 21.0

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants Achieving Responder Status at 24 Weeks of Treatment	Up to 24 weeks	The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as \<100 copies/mL serum by quantitative polymerase chain reaction \[qPCR\] assay); and 2) alanine transaminase (ALT) level normal.
Primary	Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)	The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as \<100 copies/mL serum by qPCR assay); and 2) ALT level normal.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Achieving Responder Status at 24 Weeks of Treatment	Up to 24 weeks	Includes all randomized participants receiving ≥1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)	Includes all randomized participants receiving ≥1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Units
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	PEG-Intron, 0.5 mg/kg	80	Participants
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	PEG-Intron, 1.0 mg/kg	87	Participants
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	PEG-Intron, 1.5 mg/kg	90	Participants
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	Interferon Alfa-2b	59	Participants
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	PEG-Intron, 0.5 mg/kg	52	Participants
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	PEG-Intron, 1.0 mg/kg	70	Participants
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	PEG-Intron, 1.5 mg/kg	69	Participants
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	Interferon Alfa-2b	37	Participants

Source ClinicalTrials.gov

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PEG-Intron, 0.5 mg/kg	315
Overall Study	STARTED	PEG-Intron, 1.0 mg/kg	298
Overall Study	STARTED	PEG-Intron, 1.5 mg/kg	304
Overall Study	STARTED	Interferon Alfa-2b	307
Overall Study	Treated	PEG-Intron, 0.5 mg/kg	315
Overall Study	Treated	PEG-Intron, 1.0 mg/kg	297
Overall Study	Treated	PEG-Intron, 1.5 mg/kg	304
Overall Study	Treated	Interferon Alfa-2b	303
Overall Study	COMPLETED	PEG-Intron, 0.5 mg/kg	255
Overall Study	COMPLETED	PEG-Intron, 1.0 mg/kg	229

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events628

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	Neutropenia	Blood and lymphatic system disorders	PEG-Intron, 0.5 mg/kg	13	315	26
other	Neutropenia	Blood and lymphatic system disorders	PEG-Intron, 1.0 mg/kg	18	297	37
other	Neutropenia	Blood and lymphatic system disorders	PEG-Intron, 1.5 mg/kg	25	304	36
other	Neutropenia	Blood and lymphatic system disorders	Interferon Alfa-2b	7	303	15
other	Thrombocytopenia	Blood and lymphatic system disorders	PEG-Intron, 0.5 mg/kg	7	315	13
other	Thrombocytopenia	Blood and lymphatic system disorders	PEG-Intron, 1.0 mg/kg	19	297	37
other	Thrombocytopenia	Blood and lymphatic system disorders	PEG-Intron, 1.5 mg/kg	15	304	17
other	Thrombocytopenia	Blood and lymphatic system disorders	Interferon Alfa-2b	1	303	1
other	Hypothyroidism	Endocrine disorders	PEG-Intron, 0.5 mg/kg	10	315	12
other	Hypothyroidism	Endocrine disorders	PEG-Intron, 1.0 mg/kg	18	297	22

1 to 10 of 628Source ClinicalTrials.gov

See all 628 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PEG-Intron, 0.5 mg/kg	1	315
Total, all-cause mortality	PEG-Intron, 1.0 mg/kg	0	297
Total, all-cause mortality	PEG-Intron, 1.5 mg/kg	0	304
Total, all-cause mortality	Interferon Alfa-2b	2	303
Total, other adverse events	PEG-Intron, 0.5 mg/kg	306	315
Total, other adverse events	PEG-Intron, 1.0 mg/kg	291	297
Total, other adverse events	PEG-Intron, 1.5 mg/kg	296	304
Total, other adverse events	Interferon Alfa-2b	293	303
Total, serious adverse events	PEG-Intron, 0.5 mg/kg	37	315
Total, serious adverse events	PEG-Intron, 1.0 mg/kg	32	297

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03537274

GET https://conductscience.org/api/trials/v1/NCT03537274/events?page=2

API reference For AI assistants