Overview

This trial is active, not recruiting.

Condition hepatitis b
Sponsor University of Pittsburgh
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date March 2013
End date March 2016
Trial size 40 participants
Trial identifier NCT01796457, DK082864 Immunology Treatment, U01DK082864

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome
time frame: up to 192 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B
Principal investigator Kyong-Mi Chang, MD
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 antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants. Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.