HBVPhase 4NCT04034368
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir
A Phase 4 study testing Tenofovir Alafenamide (TAF) in people with HBV, run by The First Hospital of Jilin University.
Trial summary
This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV
- What is being tested?
- Tenofovir Alafenamide (TAF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures;
- Male and female subjects,18 years of age and older, based on the date of the screening visit;
- Suboptimal Responders to Entecavir (defined as CHB patients treated with at least 12 months of ETV 0.5mg QD with prior suboptimal response viral load still detectable at week 48).
- ETV intolerance population (defined as unwilling or poor adherence to administer ETV in fasting food, renal impairment with ETV dosage adjustment required, pts with other unidentified reasons willing to switch, etc);
- Screening serum ALT level ≤ 10 × ULN;
- Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant);
- Must be willing and able to comply with all study requirements.
Who cannot join
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study;
- Co-infection with HCV, HIV, or HDV;
- Any history of, or current evidence of, clinical hepatic decompensation (i.e., moderate-severe ascites, encephalopathy or variceal hemorrhage);
- Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging);
- Abnormal hematological and biochemical parameters, including: Hemoglobin < 10 g/dl, Absolute neutrophil count < 0.75×109/L, Platelets ≤ 50×109/L, AST or ALT > 10 × ULN, Total bilirubin > 2.5 × ULN, Albumin < 3.0 g/dl, INR > 1.5 × ULN;
- Received solid organ or bone marrow transplant;
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- Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication);
- Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease);
- Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator;
- Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection(basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible;
- Known hypersensitivity to study drugs, metabolites, or formulation excipients;
- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance;
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir
This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).
- Conditions
- HBV
- Being tested
- Tenofovir Alafenamide (TAF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide (TAF)Drug
Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks；
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks； Receives: Drug: Tenofovir Alafenamide (TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main efficacy endpoint
The primary efficacy endpoint is the proportion of subjects with plasma HBV DNA levels below 20 IU/ml at Week 48.
Measured: Week 48
Secondary outcomes (7)
Key secondary efficacy endpoint
The proportion of subjects with plasma HBV DNA < 20 IU/mL at Weeks 24
Measured: Week 24
Key secondary efficacy endpoint
The change from baseline in plasma HBV DNA levels at Weeks 48
Measured: Week 48
Key secondary efficacy endpoint
The proportion of subjects with ALT normalization at Weeks 24 and 48
Measured: Week 24 and Week 48
Key secondary efficacy endpoint
The proportion of subjects with HBeAg seroconversion to anti-HBe at Weeks 48
Measured: Week 48
Key secondary efficacy endpoint
The HBV DNA maintenance rate at week 48 in ETV intolerant pts.
Measured: Week 48
Key secondary efficacy endpoint
The proportion of subjects with HBsAg seroconversion to anti-HBs at Weeks 48
Measured: Week 48
Key secondary efficacy endpoint
The incidence of drug resistant mutations at Weeks 48
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhang Gao, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034368
- Sponsor's protocol ID
- ISR-CN-18-10478
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir
- ClinicalTrials.gov ID
- NCT04034368
- Acronym / sponsor ID
- ISR-CN-18-10478
- Conditions
- HBV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Jul 2019 (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.
This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Tenofovir Alafenamide (TAF)Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks； |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures;
- Male and female subjects,18 years of age and older, based on the date of the screening visit;
- Suboptimal Responders to Entecavir (defined as CHB patients treated with at least 12 months of ETV 0.5mg QD with prior suboptimal response viral load still detectable at week 48).
- ETV intolerance population (defined as unwilling or poor adherence to administer ETV in fasting food, renal impairment with ETV dosage adjustment required, pts with other unidentified reasons willing to switch, etc);
- Screening serum ALT level ≤ 10 × ULN;
Key exclusion criteria (13 listed)
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study;
- Co-infection with HCV, HIV, or HDV;
- Any history of, or current evidence of, clinical hepatic decompensation (i.e., moderate-severe ascites, encephalopathy or variceal hemorrhage);
- Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging);
- Abnormal hematological and biochemical parameters, including: Hemoglobin < 10 g/dl, Absolute neutrophil count < 0.75×109/L, Platelets ≤ 50×109/L, AST or ALT > 10 × ULN, Total bilirubin > 2.5 × ULN, Albumin < 3.0 g/dl, INR > 1.5 × ULN;
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 Alafenamide (TAF)Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks； | Drug | Experimental Arm |
Primary outcome
Main efficacy endpoint
Time frame: Week 48
The primary efficacy endpoint is the proportion of subjects with plasma HBV DNA levels below 20 IU/ml at Week 48.
7 secondary outcomes
Key secondary efficacy endpoint
Time frame: Week 24
Key secondary efficacy endpoint
Time frame: Week 48
Key secondary efficacy endpoint
Time frame: Week 24 and Week 48
Key secondary efficacy endpoint
Time frame: Week 48
Key secondary efficacy endpoint
Time frame: Week 48
Key secondary efficacy endpoint
Time frame: Week 48
Key secondary efficacy endpoint
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Alafenamide (TAF) in people with HBV, run by The First Hospital of Jilin University.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhang Gao (15804303019, 15804303019@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main efficacy endpoint (time frame: Week 48). 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 26 Jul 2019.