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

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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
14
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Anaheim, California 92801
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Atlanta, Georgia 30342
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Atlanta, GA
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, MD
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Camperdown, New South Wales 2050
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Camperdown,
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Colombia, Maryland 21045
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Colombia, MD
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Flushing, New York 11355
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Flushing, NY
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Flushing, New York 11355
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Garden Grove, California 92844
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Garden Grove, CA
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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San Diego, California 92105
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San Diego, CA
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