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HBsAg Related Response Guided Therapy

NCT01456312 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-10-31

No results posted yet for this study

Summary

Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)

Secondary objective :

* The changes of HBsAg titer

* The rate of combined HBeAg seroconversion and HBV DNA \< 300 copies/mL

* The rate of serum HBV DNA \< 300 copies/mL ⅳ. The rate of ALT normalization

* The rate of HBsAg loss ⅵ. The rate of serum HBV DNA \< 10,000 copies/mL

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Peginterferon alfa-2a

Duration and combination

DRUG

Entecavir

combination

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Kwansik Lee, professor · Gangnam Severance Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-02-29
Completion
2016-08-31

Countries

  • South Korea

Study Locations

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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 NCT01456312 on ClinicalTrials.gov