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A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

NCT01641926 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2018-08-27

Study results available
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Summary

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen \[HBeAg\] positive or negative) who have not previously been treated with interferon.

Conditions

  • Hepatitis B, Chronic

Interventions

BIOLOGICAL

PEG-Intron™

PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

BIOLOGICAL

PEGASYS™

PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Study Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-26
Primary Completion
2016-01-21
Completion
2016-01-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641926 on ClinicalTrials.gov