Hepatitis BNCT01590615
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
An observational study of Hepatitis B, run by Gilead Sciences at 27 sites in 2 countries.
Trial summary
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Anti-HBV nucleoside/nucleotide therapy
- How many people
- 54 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 26 Apr 2012to 4 Apr 2017
- How long will I take part?
- 1 Year
- 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: Adult participants with chronic HBV infection receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy and with decompensated liver disease at time of consent.
Who may be able to join
- Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
- Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
- No history of solid organ or bone marrow transplant
- Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States23 sites
Emory University Hospital
Atlanta, Georgia, 30322
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Henry Ford Health System
Detroit, Michigan, 48202
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
The Methodist Hospital
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center for Liver Diseases and Transplantation
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90095
Methodist University Hospital
Memphis, Tennessee, 38104
Jackson Memorial Hospital
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Alegent Creighton Health
Omaha, Nebraska, 68124
Florida Hospital Transplant
Orlando, Florida, 32804
Stanford University
Palo Alto, California, 94304
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23249
University of California at San Francisco Medical Center
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98195
Saint Louis University Hospital
St Louis, Missouri, 63104
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Canada4 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
- Conditions
- Hepatitis B
- Being tested
- Anti-HBV nucleoside/nucleotide therapy
- Keywords
- Hepatitis, Hepatitis B, HBV, OLT, MELD, Renal Safety, Liver Transplant
- Medical subject headings
- Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HBV nucleoside/nucleotide therapyDrug
Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.
| Study group | Role | What they receive |
|---|---|---|
| Participants with chronic HBV infection | Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study. Receives: Drug: Anti-HBV nucleoside/nucleotide therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual.
Measured: Baseline to Year 5
Secondary outcomes (9)
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework
Measured: Baseline to Year 5
Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min
Measured: Baseline to Year 5
Change in eGFR compared to eGFR at baseline by visit window
Measured: Baseline to Year 5
Proportion of participants who received appropriate dosing relative to renal function
Measured: Baseline to Year 5
Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event
Measured: Baseline to Year 5
Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline
Measured: Baseline to Year 5
Change in MELD score and liver disease status compared to MELD score at baseline by visit window
Measured: Baseline to Year 5
Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)
Measured: Baseline to Year 5
The median number of renal related adverse events per participant over the evaluation period
Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term.
Measured: Baseline to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study start26 Apr 2012
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 54 participants (actual)
- Target duration
- 1 Year
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
- NCT01590615
- Sponsor's protocol ID
- GX-US-174-0172
- Status last verified
- Apr 2017
- First submitted
- 20 Mar 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy
- ClinicalTrials.gov ID
- NCT01590615
- Acronym / sponsor ID
- GX-US-174-0172
- Conditions
- Hepatitis B
- Keywords
- Hepatitis, Hepatitis B, HBV, OLT, MELD, Renal Safety, Liver Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2012 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 3 May 2012 (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 registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with chronic HBV infection | – | Drug: Anti-HBV nucleoside/nucleotide therapyParticipants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with chronic HBV infection receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy and with decompensated liver disease at time of consent.
Key inclusion criteria (5 listed)
- Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
- Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
- No history of solid organ or bone marrow transplant
- Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anti-HBV nucleoside/nucleotide therapySubjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis. | Drug | Participants with chronic HBV infection |
Primary outcome
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
Time frame: Baseline to Year 5
The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual.
9 secondary outcomes
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework
Time frame: Baseline to Year 5
Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min
Time frame: Baseline to Year 5
Change in eGFR compared to eGFR at baseline by visit window
Time frame: Baseline to Year 5
Proportion of participants who received appropriate dosing relative to renal function
Time frame: Baseline to Year 5
Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event
Time frame: Baseline to Year 5
Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline
Time frame: Baseline to Year 5
Change in MELD score and liver disease status compared to MELD score at baseline by visit window
Time frame: Baseline to Year 5
Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)
Time frame: Baseline to Year 5
The median number of renal related adverse events per participant over the evaluation period
Time frame: Baseline to Year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Gilead Sciences at 27 sites in 2 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 0 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: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 a confirmed increase in serum creatinine from baseline of at least one grade (time frame: Baseline to Year 5). 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 24 Apr 2017.