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Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

NCT00964665 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2011-01-06

No results posted yet for this study

Summary

This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.

Conditions

Interventions

DRUG

albinterferon alfa-2b

DRUG

albinterferon alfa-2b

DRUG

albinterferon alfa-2b

DRUG

albinterferon alfa-2b

DRUG

Pegasys®

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Institute for BioMedical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-11-30

Countries

  • China
  • Hong Kong
  • Poland
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00964665 on ClinicalTrials.gov