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Trial record 82 of 303 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

The "HBV eAg- Disease-Directly Offers" Study: Treatment Withdrawal in Patients With Early-Antigen Negative Chronic HBV (BeNEG-DO)

This study is currently recruiting participants.
Verified July 2016 by California Pacific Medical Center Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02845401
First Posted: July 27, 2016
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
California Pacific Medical Center Research Institute
  Purpose
The investigators' research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in developed countries is treated indefinitely with antiviral drugs. The investigators' study "BeNEG-DO," directly offers patients who are already taking standard oral Hepatitis B Virus (HBV) antiviral therapy for at least 192 weeks the option to stop or continue treatment. Drawing on data from pilot studies, including the investigators' own University of California, San Francisco and Sutter Institutional Review Board-approved study, the investigators will examine a finite HBV treatment strategy on clinical outcome and safety. In conjunction, the investigators will study immunologic mechanisms and gene expression profiles that correlate with and predict the post-treatment clinical course. The BeNEG-DO study could seriously question, and potentially change, the current treatment paradigm for millions of patients with CHB and also lead to new disease-terminating antiviral therapeutics.

Condition Intervention
Chronic Hepatitis B Other: Stop NA therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: "BeNEG-DO": A Study of Clinical Outcomes, Immunologic Correlates and Genetic Predictors After Treatment Withdrawal in Early-Antigen Negative (HBeAg-) Chronic Hepatitis B Virus (HBV) Infection

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Number of cases to Hepatitis B Virus Surface Antibody (HBsAb) seroconvert and clear Hepatitis B Virus Surface Antigen (HBsAg) and number of controls that remain HBsAg-Positive and HBsAb-Negative [ Time Frame: 5 years ]
    Annual seroclearance rates of 0.5%-0.8% in controls are assumed (American Association for the Study of Liver Diseases 2012 Poster 374) and equivalent to the estimated spontaneous rate (Hepatology 2009; 49:S45-55). In cases, 5-6% (based on Gastroenterology 2012 143:629:636) 5 year rates for HBsAg seroconversion (5%) or HBsAg loss only.


Secondary Outcome Measures:
  • Number of cases and controls that maintain normal alanine aminotransferase (ALT) levels and number of cases and controls that experience relapse (Elevated ALT levels) [ Time Frame: 5 years ]
    These anticipated biochemical outcomes are based on Gastroenterology 2012 143:629-636

  • Number of cases and controls that maintain HBV DNA levels <2000 International Units per milliliter (IU/ml) and number of cases and controls that experience HBV DNA levels >2000 IU/ml [ Time Frame: 5 years ]
    Hepatitis B Virus levels measured in International Units per milliliter


Estimated Enrollment: 110
Actual Study Start Date: December 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBeAg-CHB patients who stop NA Therapy

Patients with early antigen negative form of disease (HBeAg-CHB) who are already taking standard oral HBV antiviral therapy for at least 192 weeks that stop treatment.

Intervention: Cases will stop antiviral therapy

Other: Stop NA therapy
Cases will stop antiviral therapy
No Intervention: HBeAg-CHB patients continue NA Therapy

Patients with early antigen negative form of disease (HBeAg-CHB) who are already taking standard oral HBV antiviral therapy for at least 192 weeks that continue to stay on treatment.

Intervention: None. Controls will continue antiviral therapy.


Detailed Description:
A prospective case-control study of safety and clinical outcomes, and of innate and adaptive immune responses and their genetic predictors, in adult human subjects with HBeAg-CHB who either continue or stop nucleoside or nucleotide analog (NA) antiviral therapy. Immune responses will be studied using liver tissue and serial peripheral blood samples. The immunological factors selected have been chosen based on preliminary and inferential evidence. Immunologic findings will be correlated with different serologic, virologic and biochemical outcomes. Genetic predictors of the type of response and respective clinical outcomes will also be sought.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HBeAg-CHB with at least 192 weeks (3.7 years) of complete viral suppression (serum HBV DNA <50 IU/ml) on NA therapy
  2. No bridging fibrosis (≥ Metavir stage 3)
  3. Normal liver tests and platelet count
  4. Age 18-67
  5. Otherwise healthy with no serious co-morbidities
  6. Patients who are willing, prepared, and able to immediately resume antiviral treatment upon medical instruction and on satisfying study re-treatment criteria.

Exclusion Criteria:

  1. HBeAg-CHB with virologic breakthrough while on NA therapy during the prior 192 weeks (3.7 years)
  2. Age <18 or >67 years
  3. Significant co-morbidities including co-infection and significant co-existing liver disease or anemia. Mild Non-Alcoholic Fatty Liver Disease (NAFLD) without Non-Alcoholic Steatohepatitis (NASH) or associated liver enzyme elevation will be allowed.
  4. Bridging hepatic fibrosis (≥ Metavir stage 3) at the time of potential study entry

    a. Control Group: Determination will be based on historical biopsy data, imaging studies, Platelet count (<150,000), Aspartate aminotransferase to Platelet Ratio Index (APRI) <1.5) and Red Cell Distribution Width-to-Platelet Ratio (RPR) (<0.16) scores, and clinical assessment

  5. Alanine Aminotransferase (ALT) above the quoted normal range
  6. Clinical, serologic, radiological or biochemical suspicion for cirrhosis
  7. Prior liver transplantation
  8. A documented history of extrahepatic manifestations of hepatitis B, including renal disease and/or vasculitis
  9. Cases: A family history of hepatocellular carcinoma due to hepatitis B virus in a first degree family member
  10. On Prednisone or other immunosuppressive or immune-modulating therapy during the 6 months before study entry
  11. Pregnancy
  12. Patients who are not willing, prepared, and able to immediately resume antiviral treatment upon medical instruction and on satisfying re-treatment criteria

No one will be excluded on the basis of race, gender, religion, sexual orientation, or any cultural factor. An Institutional Review Board (IRB)-approved, translated consent will be used for patients that do not speak English

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845401


Contacts
Contact: Jae Shin, MPH 415-407-9430 shinj3@sutterhealth.org
Contact: Margaret Simone, BS 415-514-0865 margaret.simone@ucsf.edu

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Jae Shin, MPH    415-407-9430    shinj3@sutterhealth.org   
Contact: Jiajing Li, MPH    415-600-3594    lij101@sutterhealth.org   
Principal Investigator: Stewart Cooper, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94122
Contact: Margaret Simone, BS    415-514-0865    margaret.simone@ucsf.edu   
Contact: Jae Shin, MPH    415-407-9430    jae.shin@ucsf.edu   
Principal Investigator: Jody Baron, MD, PhD         
Sponsors and Collaborators
California Pacific Medical Center Research Institute
University of California, San Francisco
Investigators
Principal Investigator: Stewart L Cooper, MD Sutter Health - California Pacific Medical Center
Principal Investigator: Jody L Baron, MD, PhD University of California, San Francisco
  More Information

Responsible Party: California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02845401     History of Changes
Other Study ID Numbers: 1R01DK103735-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2016
First Posted: July 27, 2016
Last Update Posted: February 9, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human