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

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	4/21/2016
Start Date:	November 2010
End Date:	December 2013

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

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

Part B sub study is Open Label

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

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111