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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis B Virus

Treatments: Drug: PegIFN lambda; Drug: Entecavir; Drug: pegIFN; Drug: pegIFNα-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204762

AI452-005

2010-020387-38 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Part B sub study is Open Label

Enrollment: 197 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infection with the hepatitis B virus (HBV) and positive for the hepatitis B e antigen
• Between the ages of 18 and 70
• Have not been previously treated with an interferon
• HBV nucleos(t)ide-naive

Exclusion criteria

• Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
• Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease
• Able to tolerate oral medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

197 participants in 3 patient groups

Part A Arm 1: pegIFN (180 μg)

Experimental group

Treatment:

Drug: pegIFN

Part A Arm 2: pegIFNα-2a

Active Comparator group

Treatment:

Drug: pegIFNα-2a

Part B: pegIFN lambda + Entecavir

Experimental group

Treatment:

Drug: Entecavir

Drug: PegIFN lambda