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

Completed · Phase 2

Conditions studied: Hepatitis B Virus

In brief

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

Key facts

Study ID

NCT01204762

Run by

Bristol-Myers Squibb

People needed

197

Starts

2010-11-01

Expected to finish

2013-12-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sc Clinical Research, Inc. — Garden Grove, California, United States
• University Of California, Davis Medical Center — Sacramento, California, United States
• Research And Education, Inc. — San Diego, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Atlanta Gastroenterology Associates, Llc — Atlanta, Georgia, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Gastro Center Of Maryland — Colombia, Maryland, United States
• Medical Procare, Pllc — Flushing, New York, United States
• Office Of Sing Chan Md — Flushing, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University Of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Local Institution — Camperdown, New South Wales, Australia
• Local Institution — Liverpool, New South Wales, Australia
• Local Institution — Westmead Nsw, New South Wales, Australia
• Local Institution — Clayton Vic, Victoria, Australia
• Local Institution — Heidelberg Vic, Victoria, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution — Fremantle, Western Australia, Australia
• Heritage Medical Research Clinic, University Of Calgary — Calgary, Alberta, Canada
• Local Institution — Winnipeg, Manitoba, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Toronto Western Hospital University Health Network — Toronto, Ontario, Canada
• Local Institution — Clichy, France
• Advanced Clinical Research Institute — Anaheim, California, United States

Full record on ClinicalTrials.gov

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