Chronic Hepatitis CPhase 4BDTAFNCT04997564
The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China
A Phase 4 study testing Tenofovir Alafenamide 25 MG and Sofosbuvir / Velpatasvir in people with Chronic Hepatitis C and Chronic Hepatitis B, run by Peking University First Hospital at 1 site in China.
Trial summary
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients. All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Chronic Hepatitis B
- What is being tested?
- Tenofovir Alafenamide 25 MG and Sofosbuvir / Velpatasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Dec 2023
- 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
- Willing and able to provide written informed consent
- Male or female, age≥18 years
- Bodyweight≥40 kg
- HCV RNA positive (15 IU/mL )at Screening
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate as assessed at Screening by the Central Laboratory
- Chronic HBV/HCV coinfection (≥ 6 months) documented by prior medical history or liver biopsy. For non-cirrhotic patients, and for HBeAg positive patients, HBV DNA<20000IU/ml. For HBeAg negative patients, HBV DNA<2000IU/ml.
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- For cirrhosis patients, HBV DNA was dectable or undectable. Cirrhosis Determination (approximately 20% of subjects may have cirrhosis)
- Cirrhosis by B Ultrasound/CT/ MRI.
- Cirrhosis is defined as Fibroscan® with a result of ≥ 17.5 kPa
- Absence of cirrhosis is defined as Fibroscan with a result of <10.6 kPa within ≤ 6 months of Day 1
- Classification as treatment naïve for CHC patients Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin
- Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
- Patients with HBsAg positive as least 6 month without decompensated cirrhosis.
- Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
- Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- Male subjects and female subjects of childbearing potential who engage in heterosexualinter course must agree to use protocol specified method(s) of contraception as described in Appendix 4
- Lactating females must agree to discontinue nursing before the study drug is administered
- Subject must be of generally good health, with the exception of chronic HBV/HCV infection, as determined by the Investigator
- Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study -
Who cannot join
- Any direct antiviral drugs (DAAs) used before screening, including non-structural proteins NS3/4A inhibitor, NS5A inhibitor or NS5B polymerase inhibitor.
- Patients who received hepatitis B antiviral therapy within 6 months.
- Diagnosis of primary liver cancer or support for the following evidence: alpha-fetoprotein (AFP) >100 ng/ml or cirrhosis imaging studies of the liver revealed suspicious nodules in the liver
- A history of malignant tumors within 5 years prior to screening, except for specific cancers that have been cured by surgical resection (eg.Basal cell skin cancer, etc.), or patients suspected of having malignant tumors
- Current or previous evidence of liver decompensation, including but not limited to: Child-Pugh score Grade B or C, ascites, or hepatic encephalopathy, variceal bleeding or diuretics for the treatment of ascites.
- A current or previous history of a major medical condition or any other major medical disorder that may interfere with the individual's treatment, assessment or compliance program.
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- Clinically significant disease (except HBV, HCV) or any other major disease that may interfere with subject treatment, assessment, or protocol compliance; subjects that are currently undergoing assessment of a potentially clinically significant disease (except HBV，HCV) are also excluded.
- Gastrointestinal disease, or the condition after surgery may interfere with the absorption of the study drug.
- Difficulty in collecting blood and/or poor venous access for blood collection.
- Solid organ transplantation.
- Severe lung disease, severe heart disease or porphyria.
- Psychiatric hospitalization, attempted suicide and/or a period of disability due to mental illness in the past 5 years. Subjects with psychiatric illness (without previously mentioned conditions) who are well-controlled or who have not needed medication for the past 12 months before Day 1 may Will be included in the study.
- Serious drug allergies (such as allergic reactions or hepatotoxicity).
- Pregnant or lactating women.
- HIV or HDV infection.
- Screening ECG for clinically significant abnormalities
- Subjects have the following laboratory test parameters at screening:
- ALT > 10 Upper Limit of Normal (ULN)
- AST > 10 ULN
- Direct bilirubin > 1.5 ULN
- platelets < 50,000/L
- HbA1c > 8.5%
- eGFR < 30 mL/min/1.73 m2，estimated glomerular filtration rate (eGFR) using the Cockcroft-Gault equation，eGFR will be calculated by the Cockcroft-Gault method: eGFRCG (mL/min) = [(140 - age (yrs))× weight (kg) × (0.85 if female)] / (serum creatinine (mg/dL) × 72), where weight is total body mass in kilograms.
- Female subjects with hemoglobin < 11 g/dL; male subjects with hemoglobin < 12 g/dL
- albumin < 3 g/dL
- INR > 1.5 x ULN unless the subject has known hemophilia or remains stable for anticoagulant therapy affecting INR
- Chronic liver disease other than HCV pathogens (eg hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cholangitis).
- Known hypersensitivity to SOF/VEL, TAF and RBV (only for GT 3 cirrhosis patients).
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
XiaoYuan Xu, +86-13001185762, xiaoyuanxu6@163.com
Qian Kang, +86-18811187697, kangqian0307@163.com
About this study
Official title: The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label Trial
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.
All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
Read the detailed description
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.
All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
The primary objective of this study is:
•To evaluate efficacy and safety of SOF/VEL in HBsAg-positive patients with HCV (GT1-6) co-infection.
The secondary objectives of this study are:
- To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment.
- To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV/ HBV.
- Conditions
- Chronic Hepatitis C, Chronic Hepatitis B
- Being tested
- Tenofovir Alafenamide 25 MG, Sofosbuvir / Velpatasvir
- Keywords
- chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis B, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide 25 MGDrug
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment .
Sofosbuvir / VelpatasvirDrug
All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64.
| Study group | Role | What they receive |
|---|---|---|
| non-cirrhotic patients | Experimental | patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment Receives: Drug: Tenofovir Alafenamide 25 MG; Drug: Sofosbuvir / Velpatasvir |
| cirrhotic patients | Other | patients will be received TAF once daily for 64 weeks. In this study, after week 64, and patients will continue NUC treatment but pay by themselves. Receives: Drug: Tenofovir Alafenamide 25 MG; Drug: Sofosbuvir / Velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
Measured: The first group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
Measured: The second group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
Secondary outcomes (5)
To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Measured: From the commencement of SOF/VEL treatment(week 4) to week 64.
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The proportion of subjects with HCV is one of several viruses that cause viral hepatitis.
Measured: The first group of patients was evaluated at week 16 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
The proportion of subjects with HCV is one of several viruses that cause viral hepatitis.
Measured: The second group of patients was evaluated at week 16 to week 64
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Measured: The first group of patients was evaluated at week 4 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
The proportion of subjects with HBV is an acute and chronic liver disease caused by hepatitis B virus infection, which can be transmitted through blood, body fluids, contact, sexual contact transmission and vertical transmission of mother and child
Measured: The second group of patients was evaluated at week 4 to week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyuan XU, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997564
- Sponsor's protocol ID
- 2021XXYU-study
- Acronym
- BDTAF
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label Trial
- ClinicalTrials.gov ID
- NCT04997564
- Acronym / sponsor ID
- BDTAF / 2021XXYU-study
- Conditions
- Chronic Hepatitis C, Chronic Hepatitis B
- Keywords
- chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Aug 2021 (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.
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.
All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
Detailed description
Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.
All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.
The primary objective of this study is:
•To evaluate efficacy and safety of SOF/VEL in HBsAg-positive patients with HCV (GT1-6) co-infection.
The secondary objectives of this study are:
- To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment.
- To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV/ HBV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-cirrhotic patients | Experimental | Drug: Tenofovir Alafenamide 25 MG, Drug: Sofosbuvir / Velpatasvirpatients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment |
| cirrhotic patients | Other | Drug: Tenofovir Alafenamide 25 MG, Drug: Sofosbuvir / Velpatasvirpatients will be received TAF once daily for 64 weeks. In this study, after week 64, and patients will continue NUC treatment but pay by themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to provide written informed consent
- Male or female, age≥18 years
- Bodyweight≥40 kg
- HCV RNA positive (15 IU/mL )at Screening
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate as assessed at Screening by the Central Laboratory
Key exclusion criteria (29 listed)
- Any direct antiviral drugs (DAAs) used before screening, including non-structural proteins NS3/4A inhibitor, NS5A inhibitor or NS5B polymerase inhibitor.
- Patients who received hepatitis B antiviral therapy within 6 months.
- Diagnosis of primary liver cancer or support for the following evidence: alpha-fetoprotein (AFP) >100 ng/ml or cirrhosis imaging studies of the liver revealed suspicious nodules in the liver
- A history of malignant tumors within 5 years prior to screening, except for specific cancers that have been cured by surgical resection (eg.Basal cell skin cancer, etc.), or patients suspected of having malignant tumors
- Current or previous evidence of liver decompensation, including but not limited to: Child-Pugh score Grade B or C, ascites, or hepatic encephalopathy, variceal bleeding or diuretics for the treatment of ascites.
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 25 MGAll the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment . | Drug | cirrhotic patients, non-cirrhotic patients |
| Sofosbuvir / VelpatasvirAll the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64. | Drug | cirrhotic patients, non-cirrhotic patients |
Primary outcome
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
Time frame: The first group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR.
Time frame: The second group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）
hepatitis C virus is a chronic viral hepatitis caused by hepatitis C virus infection in the human body, it belongs to the liver virus, after the invasion of the human body, mainly into the human liver, can lead to chronic hepatitis
5 secondary outcomes
To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment
Time frame: From the commencement of SOF/VEL treatment(week 4) to week 64.
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
Time frame: The first group of patients was evaluated at week 16 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV
Time frame: The second group of patients was evaluated at week 16 to week 64
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
Time frame: The first group of patients was evaluated at week 4 to week 28
To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HBV
Time frame: The second group of patients was evaluated at week 4 to week 64
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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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.
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 Alafenamide 25 MG and Sofosbuvir / Velpatasvir in people with Chronic Hepatitis C and Chronic Hepatitis B, run by Peking University First Hospital 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 19 inclusion and 29 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 9 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XiaoYuan Xu (+86-13001185762, xiaoyuanxu6@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of treatment with SOF/VEL for 12 weeks in subjects with GT1-6 HCV/HBV co-infection as measured by the proportion of subjects with SVR. (time frame: The first group of patients was evaluated from 16 weeks to 28 weeks（for 12 weeks）). The study lists 2 primary outcomes in all. 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 9 Aug 2021.