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Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen

NCT01204762 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2015-10-09

No results posted yet for this study

Summary

At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB)

Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

Conditions

  • Hepatitis B Virus

Interventions

DRUG

pegIFN

Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks

DRUG

pegIFNα-2a

Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks

DRUG

PegIFN lambda

Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks

DRUG

Entecavir

Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT01204762 on ClinicalTrials.gov