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Trial record 17 of 440 for:    hepatitis b | Open Studies

Long Term Follow-up Registry Study of Individuals Treated in A Gilead-Sponsored Trial With Chronic Hepatitis B Infection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02258581
First received: October 3, 2014
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry study will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).


Condition Intervention
Hepatitis B
Drug: GS-4774

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long Term Follow-up Registry Study of Subjects Treated in A Gilead-Sponsored Trial With Chronic Hepatitis B Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline through Week 48 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline through Week 144 [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Rates of HBsAg loss and seroconversion through Week 144 [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Rates of hepatitis B e antigen (HBeAg) loss and seroconversion through Week 144 [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 [ Time Frame: Weeks 48, 96 and 144 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 500
Study Start Date: November 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GS-4774
    Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.

Criteria

Inclusion Criteria:

  • Must have participated in a Gilead-sponsored study for CHB
  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Must be willing and able to comply with the visit schedule and study requirements

Exclusion Criteria:

  • Patient participating or planning to participate in another clinical study with an investigational agent
  • History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02258581

Locations
United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States
Principal Investigator: Steven-Huy B Han         
Huntington Medical Research Institute Not yet recruiting
Pasadena, California, United States
Principal Investigator: Myron J Tong         
Kaiser Permanente Not yet recruiting
Sacramento, California, United States
Principal Investigator: Mary Pat Pauly         
Kaiser Permanente Not yet recruiting
San Diego, California, United States
Principal Investigator: Lisa Nyberg         
Kaiser Permanente Not yet recruiting
San Francisco, California, United States
Principal Investigator: W J Fessel         
Silicon Valley Research Institute Not yet recruiting
San Jose, California, United States
Principal Investigator: Huy Trinh         
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States
Principal Investigator: Eugene Schiff         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States
Principal Investigator: Steve Flamm         
United States, Maryland
Digestive Disease Associates, PA Not yet recruiting
Baltimore, Maryland, United States
Principal Investigator: Natarajan Ravendhran         
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States
Principal Investigator: Hannah Lee         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States
Principal Investigator: Anna Lok         
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States
Principal Investigator: Stuart C Gordon         
United States, Missouri
St. Louis University Not yet recruiting
St. Louis, Missouri, United States
Principal Investigator: Bruce Bacon         
United States, New York
Medical Procare, PLL Not yet recruiting
Flushing, New York, United States
Principal Investigator: Calvin Pan         
North Shore - LIJ Health System Not yet recruiting
Manhasset, New York, United States
Principal Investigator: Tai-Ping Lee         
United States, Virginia
Bon Secours St. Mary's Hospital of Richmond Not yet recruiting
Newport News, Virginia, United States
Principal Investigator: Mitchell L Shiffman         
New Zealand
Auckland City Hospital Not yet recruiting
Auckland, New Zealand
Principal Investigator: Edward Gane         
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Benedetta Massetto, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02258581     History of Changes
Other Study ID Numbers: GS-US-330-1508
Study First Received: October 3, 2014
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
New Zealand: Medsafe

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

ClinicalTrials.gov processed this record on November 24, 2014