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LDT Combined With TDF to Improve EGFR Decreasing in Patients With Chronic Hepatitis B Treated With TDF

NCT ID: NCT04643990

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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Chronic Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LDT Combined with TDF for Treatment

The patients take one tablet of LDTand one tablet of TDF every night and continue to 12 months.

No interventions assigned to this group

Only TAF treatment.

The patients take one tablet of TAF every night and continue to 12 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Patients had no obvious heart, lung and other important organ diseases in the past;
3. Patients have sign the informed consent form and complied with the study medication and follow-up plan.

Exclusion Criteria

1. Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
2. In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
3. With malignant tumors (including hepatocellular carcinoma);
4. 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;
5. During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;
6. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Chaoshuang Lin

Professor Lin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chaoshuang Lin, Professor

Role: PRINCIPAL_INVESTIGATOR

Third Sun Yat Sen

Locations

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Ermei Li

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chaoshuang Lin, Professor

Role: CONTACT

Phone: +8613794365980

Email: [email protected]

Ermei Li, Student

Role: CONTACT

Phone: +8613723583617

Email: [email protected]

Facility Contacts

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Ermei Li, Student

Role: primary

Other Identifiers

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0000000

Identifier Type: -

Identifier Source: org_study_id