Status:
ACTIVE_NOT_RECRUITING
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212)...
Detailed Description
Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiv...
Eligibility Criteria
Inclusion
- Ability to provide informed consent for participation in the ancillary study
Exclusion
- Children under 18 years of age
- Pregnant women
- Participants with anemia (Hgb\<10 or Hct\<30)
- Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure
- Participants with significant medical conditions, autoimmune disease or immunosuppression
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01796457
Start Date
March 1 2013
End Date
December 1 2025
Last Update
January 14 2025
Active Locations (8)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
University of Minnesota
Plymouth, Minnesota, United States, 55446