Hepatitis BNAs resistanceNCT02791386
Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy
An observational study of Hepatitis B, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- How many people
- 383 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2016to 30 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
- Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
- Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH
Who cannot join
- Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
- Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
- Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Monotherapy: A Retrospective Cohort Study
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).
- Conditions
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Patients With CHB and Drug Resistance to NA Therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Secondary outcomes (6)
Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH
Measured: Retrospectively collected from March 31, 2008 to August 15, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start22 Nov 2016
- Primary completion30 Oct 2017
- Study completion30 Oct 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 Bristol-Myers SquibbThe 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
- Retrospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791386
- Sponsor's protocol ID
- AI463-508
- Acronym
- NAs resistance
- Status last verified
- Nov 2017
- First submitted
- 1 Jun 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Monotherapy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT02791386
- Acronym / sponsor ID
- NAs resistance / AI463-508
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 6 Jun 2016 (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.
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Patients With CHB and Drug Resistance to NA Therapy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (3 listed)
- CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
- Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
- Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH
Key exclusion criteria (4 listed)
- Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
- Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
- Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
6 secondary outcomes
Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH
Time frame: Retrospectively collected from March 31, 2008 to August 15, 2016
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 14 Nov 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Bristol-Myers Squibb at 1 site in China.
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 3 inclusion and 4 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 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China (time frame: Retrospectively collected from March 31, 2008 to August 15, 2016). 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 14 Nov 2017.