Status:
COMPLETED
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Part B sub study is Open Label
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01204762
Start Date
November 1 2010
End Date
December 1 2013
Last Update
October 9 2015
Active Locations (53)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Sc Clinical Research, Inc.
Garden Grove, California, United States, 92844
3
University Of California, Davis Medical Center
Sacramento, California, United States, 95817
4
Research And Education, Inc.
San Diego, California, United States, 92105