NCT01796457

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) 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2013Dec 2026

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

13.8 years

First QC Date

February 19, 2013

Last Update Submit

January 21, 2026

Conditions

Hepatitis B

Keywords

Hepatitis BImmunologyHBVImmune tolerantImmune active

Outcome Measures

Primary Outcomes (1)

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

    HBV-specific lymphoproliferative, IFN-gamma and IL10 responses, T cell activation and costimulatory markers ( PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors Dendritic cell frequency

    up to 192 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers that have enrolled into the HBRN clinical trials (NCT01369212 or NCT01369199).

You may qualify if:

  • Ability to provide informed consent for participation in the ancillary study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Plymouth, Minnesota, 55446, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Toronto Western Hospital Liver Centre

Toronto, Ontario, Canada

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Kyong-Mi Chang, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Gastroenterology

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 21, 2013

Study Start

March 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(7)CA(1)