Hepatitis BHBVNCT03920618
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
A study testing Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in people with Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Hepatitis B, Acute-On-Chronic Liver Failure
- What is being tested?
- Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 12 to 65 years old;
- Serum total bilirubin level > 10 times upper limit of normal;
- Prothrombin time activity < 40% or prothrombin time international ratio > 1.5；
- Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Who cannot join
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
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- Using glucocorticoid;
- Patients can not follow-up;
- Investigator considering inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Doctor, +8613533978874, pzp33@hotmail.com
About this study
Official title: Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Read the detailed description
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Being tested
- Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide
- Keywords
- hepatitis b virus, acute-on-chronic liver failure, nucleotide, nucleoside
- Medical subject headings
- Hepatitis B, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Tenofovir Disoproxil FumarateDrug
Also called Viread
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Tenofovir AlafenamideDrug
Also called Vemlidy
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
| Study group | Role | What they receive |
|---|---|---|
| ETV group | Active comparator | 50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. Receives: Drug: Entecavir |
| TDF group | Active comparator | 50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long. Receives: Drug: Tenofovir Disoproxil Fumarate |
| TAF group | Experimental | 50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long. Receives: Drug: Tenofovir Alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate in the follow-up
Whether patients will survive after treatment is observed in the follow-up.
Measured: 144 week
Secondary outcomes (2)
Model for end-stage liver disease (MELD) score is recorded after treatment
The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln[serum total bilirubin (mg/dl)]+1.12ln(prothrombin time international normalized ratio)+0.95ln[serum creatinin(mg/dl)]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment.
Measured: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.
Measured: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start21 Feb 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Liang Peng, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920618
- Sponsor's protocol ID
- PL6
- Acronym
- HBV
- Status last verified
- Nov 2024
- First submitted
- 16 Apr 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Xu W, Deng Z, Wang L, Zheng X, Zhu X, Li X, Li J, Shu X, Lai J, Peng L, Xie C. Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis. Liver Res. 2024 Oct 24;8(4):295-303. doi: 10.1016/j.livres.2024.10.001. eCollection 2024 Dec.
PubMed 39958923
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT03920618
- Acronym / sponsor ID
- HBV / PL6
- Conditions
- Hepatitis B, Acute-On-Chronic Liver Failure
- Keywords
- hepatitis b virus, acute-on-chronic liver failure, nucleotide, nucleoside
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2019 (actual)
- 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 is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Detailed description
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ETV group | Active comparator | Drug: Entecavir50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. |
| TDF group | Active comparator | Drug: Tenofovir Disoproxil Fumarate50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long. |
| TAF group | Experimental | Drug: Tenofovir Alafenamide50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 12 to 65 years old;
- Serum total bilirubin level > 10 times upper limit of normal;
- Prothrombin time activity < 40% or prothrombin time international ratio > 1.5；
- Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Key exclusion criteria (9 listed)
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
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 |
|---|---|---|
| EntecavirAlso: BaracludePatients would receive treatment of oral entecavir (ETV) 0.5 mg once per day. | Drug | ETV group |
| Tenofovir Disoproxil FumarateAlso: VireadPatients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day. | Drug | TDF group |
| Tenofovir AlafenamideAlso: VemlidyPatients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day. | Drug | TAF group |
Primary outcome
Survival rate in the follow-up
Time frame: 144 week
Whether patients will survive after treatment is observed in the follow-up.
2 secondary outcomes
Model for end-stage liver disease (MELD) score is recorded after treatment
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Time frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 39958923Zhang Y, Xu W, Deng Z, Wang L, Zheng X, Zhu X, Li X, Li J, Shu X, Lai J, Peng L, Xie C. Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis. Liver Res. 2024 Oct 24;8(4):295-303. doi: 10.1016/j.livres.2024.10.001. eCollection 2024 Dec.
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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.
Liang Peng, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in people with Hepatitis B and Acute-On-Chronic Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxiong Xu, Doctor (+8613760783281, xwx1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate in the follow-up (time frame: 144 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920618, which also lists 1 linked publication.
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 29 Nov 2024.