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

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

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: GS-4774; Drug: GS-9620; Drug: Tenofovir disoproxil fumarate (TDF)

• Study Type: Observational
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia
      • Royal Prince Alfred Hospital
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Gordon and Leslie Diamond Health Care Centre
    • Vancouver, British Columbia, Canada
      • Liver and Intestinal Research Centre
  • Manitoba
    • Winnepeg, Manitoba, Canada
      • University of Manitoba
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto General Hospital
• Hong Kong
  • Lai Chi Kok, Hong Kong
    • Princess Margaret Hospital
  • Sha Tin, Hong Kong
    • Prince of Wales Hospital
• India
  • Gurarat
    • Surat, Gurarat, India
      • Nirmal Hospital Private Limited
  • Maharashtra
    • Nagpur, Maharashtra, India
      • Midas Multispecialty Hospital Private Limited
  • West Bengal
    • Kolkata, West Bengal, India
      • Dept. of Hepatology, School of Digestive & Liver Diseases
• Italy
  • Milano, Italy
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Parma, Italy
    • Azienda Ospedaliera Universitaria di Parma
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Pisa
    • Caianello, Pisa, Italy
      • Azienda Ospedaliera Universitaria Pisana
• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Korea University
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• United States
  • California
    • Sacramento, California, United States
      • Kaiser Permanente
    • San Diego, California, United States
      • Kaiser Permanente
    • San Francisco, California, United States
      • Kaiser Permanente
    • San Jose, California, United States
      • Silicon Valley Research Institute
  • Florida
    • Miami, Florida, United States
      • University of Miami
  • Hawaii
    • Honolulu, Hawaii, United States
      • The Queen's Medical Center
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States
      • Digestive Disease Associates, PA
  • Massachusetts
    • Boston, Massachusetts, United States
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan
    • Detroit, Michigan, United States
      • Henry Ford Hospital
  • Missouri
    • Saint Louis, Missouri, United States
      • St. Louis University
  • New York
    • Flushing, New York, United States
      • Medical Procare, PLL
    • Manhasset, New York, United States
      • Northwell Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Xiaoli Ma, PC
  • Virginia
    • Newport News, Virginia, United States
      • Bon Secours St. Mary's Hospital of Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Key Inclusion Criteria:

• 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

Key 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
• 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Week 144
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144	This endpoint will be measured for participants who are HBsAg positive at baseline.	Weeks 48, 144
Proportion of participants who remain HBsAg negative at Week 144	This endpoint will be measured for participants who are HBsAg negative at baseline.	Week 144
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 48
Proportions of participants with HBeAg loss and seroconversion at Week 144	This endpoint will be measured for participants who are HBeAg positive at baseline.	Week 144
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 48
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.	Week 144
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144	This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.	Weeks 48, 96 and 144
Change from Baseline in HBV DNA at Weeks 48, 96, and 144		Baseline; Week 48; Week 96; Week 144

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2014
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 14, 2017

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Vesatolimod
• Other Study ID Numbers: GS-US-330-1508; 2015-001050-16 (EudraCT Number)