Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B patients

Not Applicable

• Conditions: Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B patients; Infections and Infestations

• Registration Number: ISRCTN80908109
• Lead Sponsor: GlaxoSmithKline (China) Investment Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 4 July 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Male or female participants aged 12 years and above, at the time of signing the informed consent.
2. Participants who are diagnosed with CHB and meet the criterion of antiviral treatment for HBV infection judged by certified physicians.
3. Participants who newly initiate TDF ((only including brand TDF, Viread, and generic TDF, Beixin and Naxinde, which passed China generic quality consistency evaluation by Apr. 1 2018) monotherapy or combination therapy for the treatment of CHB by the judge of investigators at the study entry.
4. Participants who have already started TDF at the entry of study and will continue to be treated TDF (including brand TDF, Viread, and generic TDF, Beixin and Naxinde, which passed China generic quality consistency evaluation by Apr. 01 2018) with essential medical information record and lab test reports available at the initiation of TDF treatment and follow-up visit.
5. Participants who are able to perform normal activities and seek regular medical care, e.g., willing to regularly perform lab test to monitor the treatment response.
6. Participants or their legal guardians who are capable of providing signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

1. Participants who have HIV/HCV co-infection.
2. Participants who initiate or continue antiviral treatment of generic TDF which did not pass China generic quality consistency evaluation by Apr. 01, 2018
3. Participants who initiate antiviral treatment of unauthorized TDF in China.
4. Participants with a prior history of receiving any TDF monotherapy or combination therapy without essential lab test report (e.g. HBV DNA level, eGFR, serum phosphate) and medical records available at the initiation of TDF treatment and thereafter follow-up.
5. Participants who participate in any concurrent clinical trials or within 3 months priorto the entry into this study.
6. Participants who are NOT able to upload their information electronically using the study-designed smartphone APP.
7. Inability to comply with study requirements as determined by the study Investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured using patient records:<br> 1. Complete virologic response (CVR) at weeks of 48, 96, and 144.<br> 2. HBeAg loss and/or HBeAg. seroconversion in HBeAg positive patients at weeks of 48, 96 and 144.<br> 3. HBsAg loss and/or HBsAg seroconversion at weeks of 48, 96 and 144.<br> 4. Transaminase normalization at weeks of 48, 96 and 144.<br> 5. Time to CVR, defined as time from baseline to the first occurrence of CVR (if applicable)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured using patient records:<br> 1. eGFR at baseline, weeks 48, 96, and 144.<br> 2. Confirmed serum phosphate Grade 3 or 4 abnormality (<2.0 mg/dL) at weeks of 48, 98 and 144.<br> 3. Serum phosphate at baseline, weeks 48, 98 and 144.<br> 4. Phosphorus values at baseline, weeks 48, 98 and 144.<br>