Hepatitis B, ChronicPhase 4NCT06743438
Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
A Phase 4 study testing Tenofovir Amibufenamide（TMF） in people with Hepatitis B, Chronic, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Tenofovir Amibufenamide（TMF）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 30 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301
Who cannot join
- 1) Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2）Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.
- 4）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
- 5）Known hypersensitivity to study drugs, metabolites, or formulation excipients.
- 6) In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7）Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510060
About this study
Official title: Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B - a Multicenter, Open-label Follow-up Study
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.
Read the detailed description
Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Tenofovir Amibufenamide（TMF）
- Keywords
- Hepatitis B, Chronic；HBV infection
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Amibufenamide（TMF）Drug
Also called HS-10234
Once-daily oral dose of 25 mg TMF were maintained in all participants
| Study group | Role | What they receive |
|---|---|---|
| TMF treatment group | Experimental | Not described Receives: Drug: Tenofovir Amibufenamide（TMF） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
Measured: week (144+)96
Secondary outcomes (9)
The proportion of subjects with HBV DNA with lower than in the central laboratory
The proportion of patients with HBV DNA lower than in the central laboratory at week(144+)240、week(144+)336
Measured: week(144+)240、week(144+)336
Proportion of subjects with ALT normalization rate
The proportion of patients with normal ALT
Measured: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBsAg loss，HBsAg conversion
The denominator of HBsAg loss was the number of HBsAg- positive patients at 144 weeks. The denominator of HBsAg seroconversion was the number of HBsAg positive and anti-HBs negative persons at 144 weeks.
Measured: week (144+)96、week (144+)240、week (144+)336
Incidence of resistance mutation
Resistance detection when a virological breakthrough occurs
Measured: week (144+)96、week (144+)240、week (144+)336
Progression of liver disease associated with HBV infection
The proportion of patients with new HCC, Decompensated liver cirrhosis, death related to Hepatitis B
Measured: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio
The denominator of HBeAg loss was the number of HBeAg- positive patients at 144 weeks. The proportion of HBeAg seroconversion was the number of HBeAg positive and anti-HBs negative persons at 144 weeks.
Measured: week (144+)96、week (144+)240、week (144+)336
Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)
measured by dual energy x-ray absorptiometry(DXA)
Measured: week (144+)96、week (144+)240、week (144+)336
Change from Baseline in Serum Creatinine
Measured: week (144+)96、week (144+)240、week (144+)336
Change in HBV DNA from baseline
Measured: week (144+)96、week (144+)240、week (144+)336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start10 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, M.M, Principal investigator, Nanfang Hospital, Southern Medical UniversityJunqi Niu, MD, Principal investigator, The First Hospital of Jilin UniversityGuicheng Wu, MD, Principal investigator, Chongqing University Affiliated Three Gorges HospitalPeng Hu, MD, Principal investigator, The second affiliated hospital of chongqiong medical universityLvfeng Yao, Principal investigator, Mengchao Hepatopiliary Hospital of Fujian Medical UniversityWenhong Zhang, MD, Principal investigator, Huashan HospitalMinghua Su, MM, Principal investigator, First Affiliated Hospital of Guangxi Medical UniversityXiaoqing Fu, MM, Principal investigator, Hangzhou Xixi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743438
- Sponsor's protocol ID
- HS-10234-401
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B - a Multicenter, Open-label Follow-up Study
- ClinicalTrials.gov ID
- NCT06743438
- Acronym / sponsor ID
- HS-10234-401
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, Chronic；HBV infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 19 Dec 2024 (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.
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.
Detailed description
Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMF treatment group | Experimental | Drug: Tenofovir Amibufenamide（TMF） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301
Key exclusion criteria (4 listed)
- 1) Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2）Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.
- 4）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
- 5）Known hypersensitivity to study drugs, metabolites, or formulation excipients.
- 6) In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7）Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
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 |
|---|---|---|
| Tenofovir Amibufenamide（TMF）Also: HS-10234Once-daily oral dose of 25 mg TMF were maintained in all participants | Drug | TMF treatment group |
Primary outcome
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
Time frame: week (144+)96
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
9 secondary outcomes
The proportion of subjects with HBV DNA with lower than in the central laboratory
Time frame: week(144+)240、week(144+)336
Proportion of subjects with ALT normalization rate
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBsAg loss，HBsAg conversion
Time frame: week (144+)96、week (144+)240、week (144+)336
Incidence of resistance mutation
Time frame: week (144+)96、week (144+)240、week (144+)336
Progression of liver disease associated with HBV infection
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio
Time frame: week (144+)96、week (144+)240、week (144+)336
Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)
Time frame: week (144+)96、week (144+)240、week (144+)336
Change from Baseline in Serum Creatinine
Time frame: week (144+)96、week (144+)240、week (144+)336
Change in HBV DNA from baseline
Time frame: week (144+)96、week (144+)240、week (144+)336
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jinlin Hou, M.M principal investigator
Nanfang Hospital, Southern Medical University
Junqi Niu, MD principal investigator
The First Hospital of Jilin University
Guicheng Wu, MD principal investigator
Chongqing University Affiliated Three Gorges Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Amibufenamide（TMF） in people with Hepatitis B, Chronic, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory (time frame: week (144+)96). 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 19 Dec 2024.