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

NCT02258581 | Terminated

• 2 other identifiers: GS-US-330-15082015-001050-16
• Study Type: observational
• Target: 241
• Locations: 8 countries
• Sites: 37

Brief Summary

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 will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48

  This endpoint will be measured for participants who are HBsAg positive at baseline.

  Week 48

• Proportion of participants who remain HBsAg negative at Week 48

  This endpoint will be measured for participants who are HBsAg negative at baseline.

  Week 48

Secondary Outcomes (9)

• Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144

  Week 144

• Proportion of participants who achieve HBsAg loss at Weeks 48 and 144

  Weeks 48, 144

• Proportion of participants who remain HBsAg negative at Week 144

  Week 144

• Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48

  Week 48

• Proportions of participants with HBeAg loss and seroconversion at Week 144

  Week 144

Interventions

GS-4774 DRUG

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.

GS-9620 DRUG

Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.

Tenofovir disoproxil fumarate (TDF) DRUG

Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.

Also known as: Viread®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
• 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
• Must have documented HBV DNA \< 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
• Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment

You may not qualify if:

• 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
• Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
• Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (37)

Kaiser Permanente

Sacramento, California, United States

Location

Kaiser Permanente

San Diego, California, United States

Location

Kaiser Permanente

San Francisco, California, United States

Location

Silicon Valley Research Institute

San Jose, California, United States

Location

University of Miami

Miami, Florida, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Digestive Disease Associates, PA

Baltimore, Maryland, United States

Location

Tufts Medical Center

Boston, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

St. Louis University

St Louis, Missouri, United States

Location

Medical Procare, PLL

Flushing, New York, United States

Location

Northwell Health

Manhasset, New York, United States

Location

Xiaoli Ma, PC

Philadelphia, Pennsylvania, United States

Location

Bon Secours St. Mary's Hospital of Richmond

Newport News, Virginia, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Location

University of Calgary

Calgary, Alberta, Canada

Location

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Location

Liver and Intestinal Research Centre

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnepeg, Manitoba, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Nirmal Hospital Private Limited

Surat, Gurarat, India

Location

Midas Multispecialty Hospital Private Limited

Nagpur, Maharashtra, India

Location

Dept. of Hepatology, School of Digestive & Liver Diseases

Kolkata, West Bengal, India

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Caianello, Pisa, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Azienda Ospedaliera Universitaria di Parma

Parma, Italy

Location

Auckland City Hospital

Auckland, New Zealand

Location

Pusan National

Busan, South Korea

Location

Korea University

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Yonsei University

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

vesatolimod; Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 7, 2014
• Study Start: December 9, 2014
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

CA (5); US (16); HK (2); IT (4); AU (1); IN (3); KR (5); NZ (1)