Active — Not RecruitingNot Applicable

HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

United States40 participantsStarted 2013-03

Plain-language 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) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Ability to provide informed consent for participation in the ancillary study Exclusion Criteria: * 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

What they're measuring

Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome

Timeframe: up to 192 weeks

Trial details

NCT IDNCT01796457

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

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