Last updated: 07/09/2024 03:51:01
Effectiveness and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) subjects in China
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients: A 3-Year, Prospective, Real-World Study in China
Trial description: TDF was approved for the treatment of CHB in the United States in 2008 and in China in 2013 based on the results of Phase III clinical trials. As per CHB clinical practice guidelines, TDF is recommended as the first line anti-viral therapy or as rescue regimen for CHB subjects based on its high potency in suppressing hepatitis B virus (HBV) deoxyribonucleic acid (DNA), good tolerance profile and low incidence of drug resistance. The treatment experience of TDF is limited due to its late entry, high price in china since its launching in 2014, and lack of real world evidence on long-term effectiveness and safety of TDF among Chinese CHB subjects to guide clinical practices. The primary objective of the current real-world study is to evaluate the long-term effectiveness of TDF (Viread®, Beixin®, Naxinde®) in the treatment of Chinese CHB subjects. The real-world data collected from this study will provide clinical guidance to Chinese health-care practitioners (HCPs), and aid public health decision making on resource allocation. Approximately 2000 CHB subjects who newly initiate and continue TDF monotherapy or combination therapy and who already started TDF prior to entry of study will be recruited across China. The subject’s data will be collected using a novel electronic approach, i.e., Smartphone Application (App.) at study entry and thereafter at 6 month intervals for 3 years.VIREAD is a registered trademark of Gilead Sciences, Inc. BEIXIN is a registered trademark of Chengdu Brilliant Pharmaceutical Co., Ltd.. NAXINDE is a registered trademark of Qilu Pharmaceutical Co., Ltd.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects who achieve complete virologic response (CVR) at Week 48
Timeframe: Week 48
Number of subjects who achieve CVR at Week 96
Timeframe: Week 96
Number of subjects who achieve CVR at Week 144
Timeframe: Week 144
Number of subjects who achieve Hepatitis B envelope antigen (HBeAg) loss and/or HBeAg seroconversion at Week 48
Timeframe: Week 48
Number of subjects who achieve HBeAg loss and/or HBeAg seroconversion at Week 96
Timeframe: Week 96
Number of subjects who achieve HBeAg loss and/or HBeAg seroconversion at Week 144
Timeframe: Week 144
Number of subjects who achieve Hepatitis B surface antigen (HBsAg) loss and/or HBsAg seroconversion at Week 48
Timeframe: Week 48
Number of subjects who achieve HBsAg loss and/or HBsAg seroconversion at Week 96
Timeframe: Week 96
Number of subjects who achieve HBsAg loss and/or HBsAg seroconversion at Week 144
Timeframe: Week 144
Number of subjects who achieve transaminase normalization at Week 48
Timeframe: Week 48
Number of subjects who achieve transaminase normalization at Week 96
Timeframe: Week 96
Number of subjects who achieve transaminase normalization at Week 144
Timeframe: Week 144
Time to CVR
Timeframe: Up to 3 years
Secondary outcomes:
Number of subject whose estimated glomerular filtration rate (eGFR) decline >20% from Baseline at Week 48
Timeframe: Baseline and Week 48
Number of subject whose eGFR decline >20% from Baseline at Week 96
Timeframe: Baseline and Week 96
Number of subject whose eGFR decline >20% from Baseline at Week 144
Timeframe: Baseline and Week 144
Percentage change from Baseline in eGFR at Week 48
Timeframe: Baseline and Week 48
Percentage change from Baseline in eGFR at Week 96
Timeframe: Baseline and Week 96
Percentage change from Baseline in eGFR at Week 144
Timeframe: Baseline and Week 144
Change from Baseline in eGFR values at Week 48
Timeframe: Baseline and Week 48
Change from Baseline in eGFR values at Week 96
Timeframe: Baseline and Week 96
Change from Baseline in eGFR values at Week 144
Timeframe: Baseline and Week 144
Number of subjects with confirmed serum phosphate Grade 3 or 4 abnormality at Week 48
Timeframe: Week 48
Number of subjects with confirmed serum phosphate Grade 3 or 4 abnormality at Week 96
Timeframe: Week 96
Number of subjects with confirmed serum phosphate Grade 3 or 4 abnormality at Week 144
Timeframe: Week 144
Percentage change from Baseline in serum phosphate at Week 48
Timeframe: Baseline and Week 48
Percentage change from Baseline in serum phosphate at Week 96
Timeframe: Baseline and Week 96
Percentage change from Baseline in serum phosphate at Week 144
Timeframe: Baseline and Week 144
Change from Baseline in phosphorus value at Week 48
Timeframe: Baseline and Week 48
Change from Baseline in phosphorus value at Week 96
Timeframe: Baseline and Week 96
Change from Baseline in phosphorus value at Week 144
Timeframe: Baseline and Week 144
Interventions:
Drug: Tenofovir disoproxil fumarate
Enrollment:
2000
Observational study model:
Cohort
Primary completion date:
2023-30-10
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Hepatitis B, Chronic
Product
tenofovir disoproxil fumarate
Collaborators
Not applicable
Study date(s)
July 2019 to October 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Male or female subjects aged >=12 years at the timing of signing the informed consent form.
- Subjects diagnosed with CHB and meet the criterion of antiviral treatment for HBV infection judged by certified physicians.
- Subjects who have Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) co-infection.
- Subjects who initiate or continue anti-viral treatment of generic TDF which did not pass China generic quality consistency evaluation by 01-Apr-2018.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subjects aged >=12 years at the timing of signing the informed consent form.
- Subjects diagnosed with CHB and meet the criterion of antiviral treatment for HBV infection judged by certified physicians.
- Subjects who newly initiate TDF (Viread) (only including brand TDF, Viread, and generic TDF, Beixin and Naxinde, which passed China generic quality consistency evaluation by 01-Apr-2018) monotherapy or combination therapy for the treatment of CHB by the judge of investigators at the study entry.
- Subjects who have started TDF at the entry of study and will continue to be treated with TDF (Viread) (including brand TDF, Viread, and generic TDF, Beixin and Naxinde, which passed China generic quality consistency evaluation by 01-Apr-2018) with essential medical information record and lab test reports available at the initiation of TDF treatment and follow-up visit.
- At the initiation of TDF treatment: i. TDF treatment detail: TDF dose, brand name, start date; ii. Lab test (within +/-4 weeks of TDF treatment initiation): HBV DNA quantification (using high sensitive real-time Polymerase chain reaction [PCR] assays for HBV DNA quantification with lower limit of detection of 20 international units per milliliter [IU/mL]), ALT and/or aspartate aminotransferase (AST), serum creatinine and serum phosphate, HBsAg/anti-HBs and HBeAg/anti-HBe iii. Medical information: CHB diagnosis and treatment history, co morbidity, concomitant treatment
- The following visits under TDF treatment prior to entry of the study (At least once following visit record if TDF treatment > 6 months): i. Lab test: HBV DNA quantification (using high sensitive real-time PCR assays for HBV DNA quantification with lower limit of detection of 20IU/ml), Serum creatinine and Serum phosphate ii. Medical information: co-morbidity, concomitant treatment, TDF treatment information
- Subjects 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.
- Subjects 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 protocol.
Essential medical information record and lab test reports:
Exclusion criteria:
- Subjects who have Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) co-infection.
- Subjects who initiate or continue anti-viral treatment of generic TDF which did not pass China generic quality consistency evaluation by 01-Apr-2018.
- Subjects who initiate antiviral treatment of unauthorized TDF in China.
- Subjects 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.
- Subjects who participate in any concurrent clinical trials or within 3 months prior to the entry into this study.
- Subjects who are not able to upload their information electronically using the study-designed smartphone App.
- Subjects inability to comply with study requirements as determined by the study investigator.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2023-30-10
Actual study completion date
2023-30-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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