Chronic Hepatitis bNCT04195074
Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b
A study testing Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in people with Chronic Hepatitis b, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
- ALT≥2×ULN；
- 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.
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 Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b
This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b
Read the detailed description
Chronic hepatitis b (CHB) remains a serious public health problem 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 CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
- Conditions
- Chronic Hepatitis b
- Being tested
- Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide
- Keywords
- chronic hepatitis b, nucleoside, nucleotide
- 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.
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 | Experimental | 100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. Receives: Drug: Entecavir |
| TDF group | Experimental | 100 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 | 100 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.
Rate of renal function decline
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Measured: 144 week
Rate of hypercalcemia
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
Measured: 144 week
Secondary outcomes (4)
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value.
Measured: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen loss rate
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
Measured: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.
Measured: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen seroconversion rate
hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody
Measured: 0 week, 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 posted11 Dec 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- 300 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
- NCT04195074
- Sponsor's protocol ID
- PL8
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b
- ClinicalTrials.gov ID
- NCT04195074
- Acronym / sponsor ID
- PL8
- Conditions
- Chronic Hepatitis b
- Keywords
- chronic hepatitis b, nucleoside, nucleotide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 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 and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b
Detailed description
Chronic hepatitis b (CHB) remains a serious public health problem 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 CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
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 | Experimental | Drug: Entecavir100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long. |
| TDF group | Experimental | Drug: Tenofovir Disoproxil Fumarate100 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 Alafenamide100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
- ALT≥2×ULN；
- 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
Rate of renal function decline
Time frame: 144 week
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Rate of hypercalcemia
Time frame: 144 week
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
4 secondary outcomes
hepatitis b virus(HBV) DNA undetectable rate
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen loss rate
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b s antigen loss rate
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
hepatitis b e antigen seroconversion rate
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Chronic Hepatitis B
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.
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 Chronic Hepatitis b, 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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?
Results are not available in the source record.
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?
Rate of renal function decline (time frame: 144 week). 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 17 Dec 2019.