NCT01204762

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

Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

Part B sub study is Open Label

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-09-17
• Last updated: 2015-10-09

Locations

53 sites across 11 countries: United States, Australia, Canada, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Taiwan