Chronic Hepatitis BNCT04650828
TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months
An observational study of Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TDF and Tenofovir Disoproxil Fumarate 300 MG
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months
Who may be able to join
- Male or female patients, aged 18 to 70 years, including 18 and 70 years old;
- Patients with poor response to tenofovir for 12 months did not obtained HBeAg seroconversionPatients with poor response to tenofovir for 12 months who didn't obtain HBeAg seroconversion choosed to continue taking tenofovir or take tenofovir combined with Tbl for 12months;
- Persons were willing to sign informed consent and comply with medication regimen and follow-up.
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
Chaoshuang Lin
Guangzhou
shufang pan, 13557981048, psf980730@163.com
About this study
Official title: TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months
Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.
Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.
Read the detailed description
This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .
- Conditions
- Chronic Hepatitis B
- Being tested
- TDF, Tenofovir Disoproxil Fumarate 300 MG
- 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.
TDFDrug
TDF combined with telbivudine (LDT) for 12 months
Tenofovir Disoproxil Fumarate 300 MGDrug
TDF monotherapy was continued for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental:person with TDF+LDT | TDF combined with LDT for 12 months Receives: Drug: TDF | |
| Active comparator:person with TDF | TDF monotherapy was continued for 12 months Receives: Drug: Tenofovir Disoproxil Fumarate 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion rates
HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment
Measured: 12months
HBeAg seroconversion rates
HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment
Measured: 24months
Secondary outcomes (3)
HBeAg negative rate
HBeAg negative rate of tenofovir combined with telbivudine treatment at 12 and 24 months
Measured: 12 and 24months
ALT normalization rate
ALT normalization rate of tenofovir combined with telbivudine treatment at 12 and 24 months
Measured: 12 and 24months
Renal function index
Renal function index of tenofovir combined with telbivudine treatment at 12 and 24 months
Measured: 12 and 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 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
- 1 Year
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650828
- Sponsor's protocol ID
- 00000001
- Status last verified
- Jan 2021
- First submitted
- 20 Oct 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months
- ClinicalTrials.gov ID
- NCT04650828
- Acronym / sponsor ID
- 00000001
- 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 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Dec 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.
Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.
Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.
Detailed description
This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:person with TDF+LDT | – | Drug: TDFTDF combined with LDT for 12 months |
| Active comparator:person with TDF | – | Drug: Tenofovir Disoproxil Fumarate 300 MGTDF monotherapy was continued for 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months
Key inclusion criteria (3 listed)
- Male or female patients, aged 18 to 70 years, including 18 and 70 years old;
- Patients with poor response to tenofovir for 12 months did not obtained HBeAg seroconversionPatients with poor response to tenofovir for 12 months who didn't obtain HBeAg seroconversion choosed to continue taking tenofovir or take tenofovir combined with Tbl for 12months;
- Persons were willing to sign informed consent and comply with medication regimen and follow-up.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDFTDF combined with telbivudine (LDT) for 12 months | Drug | Experimental:person with TDF+LDT |
| Tenofovir Disoproxil Fumarate 300 MGTDF monotherapy was continued for 12 months | Drug | Active comparator:person with TDF |
Primary outcome
HBeAg seroconversion rates
Time frame: 12months
HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment
HBeAg seroconversion rates
Time frame: 24months
HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment
3 secondary outcomes
HBeAg negative rate
Time frame: 12 and 24months
ALT normalization rate
Time frame: 12 and 24months
Renal function index
Time frame: 12 and 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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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.
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 12 Jan 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg seroconversion rates (time frame: 12months). 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 12 Jan 2021.