Clinical trial NCT02258581: Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
Official title: A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
timeFrame: Week 48
measure: Proportion of participants who remain HBsAg negative at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
timeFrame: Week 144
measure: Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
timeFrame: Weeks 48, 144
measure: Proportion of participants who remain HBsAg negative at Week 144
timeFrame: Week 144
measure: Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48
timeFrame: Week 48
measure: Proportions of participants with HBeAg loss and seroconversion at Week 144
timeFrame: Week 144
measure: Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48
timeFrame: Week 48
measure: Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
timeFrame: Week 144
measure: Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144
timeFrame: Weeks 48, 96 and 144
measure: Change from Baseline in HBV DNA at Weeks 48, 96, and 144
timeFrame: Baseline; Week 48; Week 96; Week 144
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: San Jose
country: United States
facility: Silicon Valley Research Institute
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Flushing
country: United States
facility: Medical Procare, PLL
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: Xiaoli Ma, PC
state: Pennsylvania
city: Newport News
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond
state: Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Liver and Intestinal Research Centre
state: British Columbia
city: Winnepeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Surat
country: India
facility: Nirmal Hospital Private Limited
state: Gurarat
city: Nagpur
country: India
facility: Midas Multispecialty Hospital Private Limited
state: Maharashtra
city: Kolkata
country: India
facility: Dept. of Hepatology, School of Digestive & Liver Diseases
state: West Bengal
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Caianello
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Pisa
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria di Parma
city: Busan
country: Korea, Republic of
facility: Pusan National
city: Seoul
country: Korea, Republic of
facility: Korea University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: