Chronic Hepatitis BNCT02258581
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
An observational study of Chronic Hepatitis B, run by Gilead Sciences at 37 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GS-4774, GS-9620 and Tenofovir disoproxil fumarate (TDF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 241 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 9 Dec 2014to 14 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
United States16 sites
University of Michigan
Ann Arbor, Michigan
Digestive Disease Associates, PA
Baltimore, Maryland
Tufts Medical Center
Boston, Massachusetts
Northwestern University
Chicago, Illinois
Henry Ford Hospital
Detroit, Michigan
Medical Procare, PLL
Flushing, New York
The Queen's Medical Center
Honolulu, Hawaii
Northwell Health
Manhasset, New York
University of Miami
Miami, Florida
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia
Xiaoli Ma, PC
Philadelphia, Pennsylvania
Kaiser Permanente
Sacramento, California
Kaiser Permanente
San Diego, California
Kaiser Permanente
San Francisco, California
Silicon Valley Research Institute
San Jose, California
St. Louis University
St Louis, Missouri
Canada5 sites
University of Calgary
Calgary, Alberta
Toronto General Hospital
Toronto, Ontario
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia
Liver and Intestinal Research Centre
Vancouver, British Columbia
University of Manitoba
Winnepeg, Manitoba
South Korea5 sites
Pusan National
Busan
Korea University
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Yonsei University
Seoul
Italy4 sites
Azienda Ospedaliera Universitaria Pisana
Caianello, Pisa
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera Universitaria di Parma
Parma
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia
India3 sites
Dept. of Hepatology, School of Digestive & Liver Diseases
Kolkata, West Bengal
Midas Multispecialty Hospital Private Limited
Nagpur, Maharashtra
Nirmal Hospital Private Limited
Surat, Gurarat
Hong Kong2 sites
Princess Margaret Hospital
Lai Chi Kok
Prince of Wales Hospital
Shatin
About this study
Official title: 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).
- Conditions
- Chronic Hepatitis B
- Being tested
- GS-4774, GS-9620, Tenofovir disoproxil fumarate (TDF)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-4774Drug
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-9620Drug
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
Also called Viread®
Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 48
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 48, 96 and 144
Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Measured: Baseline; Week 48; Week 96; Week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start9 Dec 2014
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258581
- Sponsor's protocol ID
- GS-US-330-1508
- Other IDs
- 2015-001050-16, 2015
- Status last verified
- Sep 2017
- First submitted
- 3 Oct 2014
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT02258581
- Acronym / sponsor ID
- GS-US-330-1508
- Conditions
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2014 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-4774Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection. | Drug | – |
| GS-9620Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection. | Drug | – |
| Tenofovir disoproxil fumarate (TDF)Also: Viread®Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection. | Drug | – |
Primary outcome
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
Time frame: Week 48
This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants who remain HBsAg negative at Week 48
Time frame: Week 48
This endpoint will be measured for participants who are HBsAg negative at baseline.
9 secondary outcomes
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
Time frame: Week 144
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
Time frame: Weeks 48, 144
Proportion of participants who remain HBsAg negative at Week 144
Time frame: Week 144
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48
Time frame: Week 48
Proportions of participants with HBeAg loss and seroconversion at Week 144
Time frame: Week 144
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48
Time frame: Week 48
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
Time frame: Week 144
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
Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Time frame: Baseline; Week 48; Week 96; Week 144
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Gilead Sciences at 37 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, South Korea, Italy, India and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.