Chronic Hepatitis BNCT04643990
LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF
An observational study of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Chronic hepatitis B (CHB) is an important public health problem in the world. There are still more than 250 million chronic hepatitis B virus (CHB) infected people in the world. Its preventive effect has reached a relatively ideal effect, but its therapeutic effect still has great room for improvement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2022
- How long will I take part?
- 12 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mainly patients with decreased glomerular filtration rate after taking TDF and meeting the above inclusion criteria and not meeting any of the appeal exclusion criteria.
Who may be able to join
- After TDF treatment, patients with eGFR<90ml/min/1.72m² and without obvious renal damage before taking the medicine switch to LDT combined with TDF, or switch to TAF treatment;
- Patients had no obvious heart, lung and other important organ diseases in the past;
- Patients have sign the informed consent form and complied with the study medication and follow-up plan.
Who cannot join
- Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
- In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
- With malignant tumors (including hepatocellular carcinoma);
- Concomitant with other liver diseases, such as alcoholic liver disease, autoimmune disease, or other systemic diseases involving the liver, such as hemochromatosis, Alpha-1 antitrypsin deficiency, or Wilson disease;
- During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;
- There are any other factors that the researcher thinks are not suitable for inclusion in the study, or that may affect the patient's participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ermei Li
Guangzhou, Guangdong, 510630
Ermei Li, Student, +8613723583617, liermei2020@163.com
About this study
Official title: Clinical Analysis of LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF
Chronic hepatitis B (CHB) is an important public health problem in the world. There are still more than 250 million chronic hepatitis B virus (CHB) infected people in the world. Its preventive effect has reached a relatively ideal effect, but its therapeutic effect still has great room for improvement.
Tenofovir(TDF) is the first-line antiviral treatment with good clinical efficacy. However, some patients who take TDF for a long time have different degrees of renal dysfunction, which limits the use of TDF in these patients.
Read more
Tenofovir Alafenamide Fumarate (TAF) has better plasma stability and stronger liver targeting, and reduces the side effects of renal function damage and bone mineral density reduction. Telbivudine (LDT), a nucleoside analogue, has the advantages of rapidly reducing HBV viral load and high HBeAg seroconversion rate.
In addition, prospective studies have shown that LDT can improve the estimated glomerular filtration rate (EGFR).Therefore, this study aims to explore the clinical study of LDT combined with TDF and TAF in patients treated with tenofovir and EGFR < 90ml / min / 1.72m².
Read the detailed description
This is a multi-center, open-label clinical study. This study was aimed to explore the LDT combined with TDF and TAF in patients treated with TDF and EGFR < 90ml / min / 1.72m².The primary objectives of this study is as follows: To access the effectiveness and safety of 12-month treatment with LDT combined with TDF and only TAF in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with HBV DNA (DNA:Hepatitis B virus deoxyribonucleic acid)was evaluated. This study aims to enroll 200 patients with CHB in each treatment group. Patients with CHB having received the TAF previously but EGFR < 90ml / min / 1.72m² subsequently fulfills the indication of antiviral therapy will be administered with LDT combined with TDF and only TAF treatment. After 12-month treatment, all the patients will be followed up for 12 months.
- Conditions
- Chronic Hepatitis B
- 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.
| Study group | Role | What they receive |
|---|---|---|
| LDT Combined with TDF for Treatment | The patients take one tablet of LDTand one tablet of TDF every night and continue to 12 months. | |
| Only TAF treatment. | The patients take one tablet of TAF every night and continue to 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA
Hepatitis B virus DNA is double-deoxyribonucleotide, which is a marker of hepatitis B virus replication.
Measured: 6 and 12 months
Secondary outcomes (2)
HBeAg seroconversion rate
HBeAg seroconversion rate means that HBeAg cannot be detected in the patient's serum but HBeAb can be detected.
Measured: 3,6,9,and 12 months
Estimated glomerular filtration rate
Estimating the glomerular filtration rate can roughly reflect the condition of kidney function.
Measured: 3,6,9,and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Dec 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Dec 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaoshuang Lin, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Chaoshuang Lin, Professor, Principal investigator, Third Sun Yat Sen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643990
- Sponsor's protocol ID
- 0000000
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2020
- Last updated
- 22 Dec 2020
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF
- ClinicalTrials.gov ID
- NCT04643990
- Acronym / sponsor ID
- 0000000
- Conditions
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 25 Nov 2020 (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.
Chronic hepatitis B (CHB) is an important public health problem in the world. There are still more than 250 million chronic hepatitis B virus (CHB) infected people in the world. Its preventive effect has reached a relatively ideal effect, but its therapeutic effect still has great room for improvement.
Tenofovir(TDF) is the first-line antiviral treatment with good clinical efficacy. However, some patients who take TDF for a long time have different degrees of renal dysfunction, which limits the use of TDF in these patients.
Tenofovir Alafenamide Fumarate (TAF) has better plasma stability and stronger liver targeting, and reduces the side effects of renal function damage and bone mineral density reduction. Telbivudine (LDT), a nucleoside analogue, has the advantages of rapidly reducing HBV viral load and high HBeAg seroconversion rate.
In addition, prospective studies have shown that LDT can improve the estimated glomerular filtration rate (EGFR).Therefore, this study aims to explore the clinical study of LDT combined with TDF and TAF in patients treated with tenofovir and EGFR < 90ml / min / 1.72m².
Detailed description
This is a multi-center, open-label clinical study. This study was aimed to explore the LDT combined with TDF and TAF in patients treated with TDF and EGFR < 90ml / min / 1.72m².The primary objectives of this study is as follows: To access the effectiveness and safety of 12-month treatment with LDT combined with TDF and only TAF in patients with CHC and cirrhosis in real-world clinical practice in Southern area of China. The proportion of participants with HBV DNA (DNA:Hepatitis B virus deoxyribonucleic acid)was evaluated. This study aims to enroll 200 patients with CHB in each treatment group. Patients with CHB having received the TAF previously but EGFR < 90ml / min / 1.72m² subsequently fulfills the indication of antiviral therapy will be administered with LDT combined with TDF and only TAF treatment. After 12-month treatment, all the patients will be followed up for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDT Combined with TDF for Treatment | – | –The patients take one tablet of LDTand one tablet of TDF every night and continue to 12 months. |
| Only TAF treatment. | – | –The patients take one tablet of TAF every night and continue to 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mainly patients with decreased glomerular filtration rate after taking TDF and meeting the above inclusion criteria and not meeting any of the appeal exclusion criteria.
Key inclusion criteria (3 listed)
- After TDF treatment, patients with eGFR<90ml/min/1.72m² and without obvious renal damage before taking the medicine switch to LDT combined with TDF, or switch to TAF treatment;
- Patients had no obvious heart, lung and other important organ diseases in the past;
- Patients have sign the informed consent form and complied with the study medication and follow-up plan.
Key exclusion criteria (6 listed)
- Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
- In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
- With malignant tumors (including hepatocellular carcinoma);
- Concomitant with other liver diseases, such as alcoholic liver disease, autoimmune disease, or other systemic diseases involving the liver, such as hemochromatosis, Alpha-1 antitrypsin deficiency, or Wilson disease;
- During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;
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
HBV DNA
Time frame: 6 and 12 months
Hepatitis B virus DNA is double-deoxyribonucleotide, which is a marker of hepatitis B virus replication.
2 secondary outcomes
HBeAg seroconversion rate
Time frame: 3,6,9,and 12 months
Estimated glomerular filtration rate
Time frame: 3,6,9,and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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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.
Chaoshuang Lin, Professor principal investigator
Third Sun Yat Sen
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 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 3 inclusion and 6 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 22 Dec 2020. 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 Chaoshuang Lin, Professor (+8613794365980, linchaoshuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA (time frame: 6 and 12 months). 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 22 Dec 2020.