Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B patients
| ISRCTN | ISRCTN80908109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80908109 |
- Submission date
- 04/04/2023
- Registration date
- 19/06/2023
- Last edited
- 13/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
HBV infection is particularly important in the Asian-Pacific region and China. Tenofovir disoproxil fumarate (TDF) was approved for the treatment of Chronic Hepatitis B (CHB) in the U.S. in 2008 and in China in 2013 based on Phase III clinical trials results. Since launching in China in 2014, the treatment experience of TDF is limited due to poor access. One important reason was the lack of real-world evidence on long-term effectiveness and safety of TDF among Chinese CHB patients to guide clinical practice. The generation of real-world evidence from this study will provide clinical guidance to Chinese healthcare care professional, address their concerns, and aid public health decision making on resource allocation. To assess the effectiveness among overall and sub-group Chinese CHB patients who receive TDF treatment in real-world.
Who can participate?
TDF-naïve patients with confirmed diagnosis of CHB who newly initiate (Viread) monotherapy or combination therapy for the treatment of CHB will be invited to participate in this study
What does the study involve?
The study is a non-interventional real-world study, and participants will be diagnosed, treated, and monitored as in real clinical practice according to their physicians’ judgement without additional interventions and procedures. Paticipants data will be collected from lab test reports or medical records via electronic approaches (Smartphone App) at the entry of the study and thereafter at 6-month intervals for 3 years. There are no mandatory visits during the study period, however, according to the CHB clinical practice and CHB management guideline, CHB patients on anti-viral treatment should be monitored for at least every 6 months.
What are the possible benefits and risks of participating?
Not applicable for this non-interventional real-world study.
Where is the study run from?
The Second Affiliated Hospital of Chongqing Medical University (China)
When is the study starting and how long is it expected to run for?
October 2018 to December 2023
Who is funding the study?
GlaxoSmithKline (China) Investment Co., Ltd
Who is the main contact?
Dr Hong Ren, renhong0531@126.com
Contact information
Principal Investigator
288 Tianwen Avenue
Nan’an District
Chongqing
400060
China
 ORCID ID |
0009-0002-0622-6062 |
|---|---|
| Phone | +86 13983888786 |
| renhong0531@126.com |
Study information
| Study design | Multi-center prospective longitudinal observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients: A 3-Year, Prospective, Real-World Study in China |
| Study objectives | To assess the effectiveness among overall and sub-group Chinese chronic hepatitis B (CHB) patients who receive tenofovir disoproxil fumarate (TDF) treatment in the real-world. |
| Ethics approval(s) |
Approved 11/09/2018, Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University (288 Tianwen Avenue, Nan’an District, Chongqing, -, China; +86-023-62888436; 1270161476@qq.com), ref: 2019-7-3 |
| Health condition(s) or problem(s) studied | Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B patients |
| Intervention | This was a non-interventional real-world study. Chronic Hepatits B (CHB) patients treated with TDF were included, patient data will be collected at the entry of this study and thereafter at 6-month intervals for 3 years. Enrollment started on 16th July 2019 and ended on 30th November 2020. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tenofovir disoproxil fumarate |
| Primary outcome measure | Measured using patient records: 1. Complete virologic response (CVR) at weeks of 48, 96, and 144. 2. HBeAg loss and/or HBeAg. seroconversion in HBeAg positive patients at weeks of 48, 96 and 144. 3. HBsAg loss and/or HBsAg seroconversion at weeks of 48, 96 and 144. 4. Transaminase normalization at weeks of 48, 96 and 144. 5. Time to CVR, defined as time from baseline to the first occurrence of CVR (if applicable) |
| Secondary outcome measures | Measured using patient records: 1. eGFR at baseline, weeks 48, 96, and 144. 2. Confirmed serum phosphate Grade 3 or 4 abnormality (<2.0 mg/dL) at weeks of 48, 98 and 144. 3. Serum phosphate at baseline, weeks 48, 98 and 144. 4. Phosphorus values at baseline, weeks 48, 98 and 144. |
| Overall study start date | 12/10/2018 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 2,000 |
| Total final enrolment | 2000 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 16/07/2019 |
| Date of final enrolment | 30/11/2020 |
Locations
Countries of recruitment
- China
Study participating centres
Chongqing
400060
China
Shayibake district
Urumqi
Xinjiang
830000
China
Taiyuan
030000
China
Nangang district
Harbin
150000
China
Heping district
Shenyang
110000
China
Nankai district
Tianjin
300000
China
Guandu district
Kunming
650000
China
Qiqihar city
Qiqihar
161000
China
Baqiao district
Xi'an
710000
China
Fengtai district
Beijing
100000
China
Nanchang
330000
China
Kunming
650000
China
Changchun
130000
China
Nanjing
230000
China
Longgang district
Shenzhen
518000
China
Wuhan
430000
China
Sponsor information
Industry
Building A Ocean International
Center 56, Mid 4th East Ring Rd
Chao Yang district, Beijing
Beijing
100025
China
| Phone | +86 10 5925 2888 |
|---|---|
| jiafei.x.yin@gsk.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 09/11/2018 | 13/06/2023 | No | No |
Additional files
Editorial Notes
13/06/2023: Trial's existence confirmed by Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University.
