Chronic Hepatitis bPhase 2NCT05238844
A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection
A Phase 2 study testing ATI-2173 25mg, Vebicorvir 300mg and Viread 300Mg Tablet in people with Chronic Hepatitis b, run by Antios Therapeutics, Inc at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in volunteers with chronic hepatitis B virus infection. Volunteers will be administered multiple oral doses of ATI-2173 vebicorvir in combination with tenofovir disoproxil fumarate and assessed for safety… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- ATI-2173 25mg, Vebicorvir 300mg and Viread 300Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Apr 2022to 25 May 2022
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- If female, meets one of the following criteria:
- Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
- Abstinence from heterosexual intercourse from the first study drug administration through to at least 6 months after the last dose of the study drug or until completion of the study, whichever is longer
- Use a non-hormonal intrauterine device, from at least 28 days prior to the first study drug administration through to at least 6 months after the last dose of the study drug or until completion of the study, whichever is longer, with a male condom or a diaphragm/cervical cap plus spermicide from the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer
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- Use of a double-barrier method
- Male partner vasectomized at least 6 months prior to the first study drug administration Or
- Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (ie, at least 1 year without menses without an alternative medical condition prior to the first study drug administration and follicle-stimulating hormone [FSH] levels within the normal ranges for postmenopausal state of the clinical site at screening). If the subject engages in sexual relations, a barrier method (male or female condom) should be used to prevent the spread of HBV.
- If male, meets one of the following criteria:
- Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
- Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) Or c) Is unable to procreate; defined as surgically sterile (ie, has undergone a vasectomy at least 6 months prior to the first study drug administration). If the subject engages in sexual relations, a barrier method (male or female condom) should be used to prevent the spread of HBV.
- Male or female aged at least 18 years but not older than 70 years
- Body mass index (BMI) within 18.0 kg/m2 to 35.0 kg/m2, inclusively
- Light-, non- or ex-smoker (A light smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration [refer to APPENDIX 7 for conversions of nicotine usage]. An ex-smoker is defined as someone who completely stopped using nicotine products for at least 6 months prior to the first study drug administration)
- Serum HBsAg positive at screening and at least 6 months prior to screening.
- Serum HBeAg positive and HBV DNA ≥ 20,000 IU/mL, or serum HBeAg negative and HBV DNA ≥ 2,000 IU/mL at screening
- ALT and AST < 5 times the upper limit of normal (ULN) at screening and on the day prior to the first study drug administration (Day -1)
Who cannot join
- Female who is lactating at screening
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- History of significant hypersensitivity to clevudine, tenofovir disoproxil fumarate or any related products (including excipients of ATI-2173, tenofovir disoproxil fumarate, and the placebo) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of clinically significant muscle disorders, myopathies or other forms of liver disease
- Presence of any clinically significant disease, as captured in the medical history or evidence of findings on the physical examination, vital sign assessment and/or ECG assessment, and that would otherwise exclude subject from eligibility in the context of all other listed inclusion and exclusion criteria, as determined by an Investigator
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- Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
- Any history of tuberculosis
- Active illicit drug use including, but not limited to, cocaine, heroin and methamphetamine (the use of cannabinoids is acceptable)
- Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Use of amiodarone in the 28 days prior to the first study drug administration
- Presence or history of clinically significant gastrointestinal or kidney disease, or surgery that may affect drug bioavailability
- Cirrhosis of the liver as determined by one of the following:
- A score greater than F2 for liver fibrosis by FibroScan or FibroSure test within 6 months prior to screening or at the time of screening Or
- A score greater than F2 on liver biopsy within 12 months prior to screening or at the time of screening
- History of or known presence of hepatocellular carcinoma
- Acute infection or any other clinically significant illness within 14 days of Day 1 of the study
- History of organ transplantation
- Presence of uncontrolled hypertension
- Positive screening results to HIV Ag/Ab combo or hepatitis C virus tests
- Any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
- Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
- Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
- Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration
- Previous approved or investigational treatment for HBV, including nucleoside therapy, other than treatment by tenofovir or interferon alpha. Prior treatment with tenofovir or interferon alpha must have been discontinued at least 6 months prior to Screening.
- Positive screening results to hepatitis D virus (HDV) tests
- History of significant hypersensitivity to excipients of vebicorvir or its placebo
- Current or prior use of prohibited concomitant medications as defined in Section 4.5.1.
- Participation in the ANTT201 study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Moldova1 site
Republican Clinical Hospital "Timofei Mosneaga" Arensia EM Unit
Chisinau, Republic of Moldova
Ukraine1 site
Medical Center of Limited Liability Company "Harmoniya krasy"
Kyiv
About this study
Official title: A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection
This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in volunteers with chronic hepatitis B virus infection. Volunteers will be administered multiple oral doses of ATI-2173 vebicorvir in combination with tenofovir disoproxil fumarate and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.
- Conditions
- Chronic Hepatitis b
- Being tested
- ATI-2173 25mg, Vebicorvir 300mg, Viread 300Mg Tablet
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-2173 25mgDrug
ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth.
Vebicorvir 300mgDrug
Vebicorvir (formerly ABI-H0731) is an orally administered, potent and selective small molecule inhibitor of the HBV core protein
Viread 300Mg TabletDrug
Viread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus.
| Study group | Role | What they receive |
|---|---|---|
| ATI-2173 25mg, Vebicorvir 300mg and Tenofovir 300mg | Experimental | Subjects randomized to active arm will receive active 25mg ATI-2173 + active Vebicorvir 300mg + active Tenofovir 300mg Receives: Drug: ATI-2173 25mg; Drug: Vebicorvir 300mg; Drug: Viread 300Mg Tablet |
| Tenofovir Disoproxil Fumarate | Active comparator | Subjects randomized to placebo arm will receive placebo 25mg ATI-2173 + placebo Vebicorvir 300mg + active Tenofovir 300mg Receives: Drug: Viread 300Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE)
Measured: Through study completion, an average of 1 year
The percentage of subjects who experienced at least 1 treatment-emergent serious adverse event (TE SAE)
Measured: Through study completion, an average of 1 year
The percentage of subjects who experienced a treatment-emergent dose-limiting toxicity (TE DLT)
Measured: Through study completion, an average of 1 year
The percentage of subjects who experienced at least 1 treatment-emergent Division of AIDS (DAIDS) Grade 1, 2, 3, 4, or 5 laboratory abnormality
Measured: Through study completion, an average of 1 year
The percentage of subjects who discontinued the study drug due to a TEAE
Measured: Through study completion, an average of 1 year
Alanine aminotransferase and aspartate aminotransferase levels versus time
Measured: Through study completion, an average of 1 year
Time to HBV viral load relapse in HBV-infected subjects as measured by HBV DNA viral load in IU/mL
Measured: Through study completion, an average of 1 year, which is 6 months after end of treatment
Secondary outcomes (43)
Baseline-adjusted maximal reduction in HBV DNA viral load (Emax,HBV) through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year, which is 6 months after end of treatment
TEmax,HBV through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year, which is 6 months after end of treatment
AUEC(HBV) through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year, which is 6 months after end of treatment
Proportion of subjects with HBV DNA sustained viral response as measured by HBV DNA viral load at 6 months after end of treatment
Measured: Through study completion, an average of 1 year, which is 6 months after end of treatment
Cmax of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
Tmax of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
Ctrough of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
Ctau of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
AUC0-24 of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
AUCtau of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
t1/2 of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
RAC(Cmax) of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
RAC(AUC) of ATI-2173, clevudine and M1 in plasma
Measured: Through study completion, an average of 1 year
Proportion of subjects with HBV SVR12, SVR18, and SVR24months
Measured: Through study completion, an average of 1 year, or through 24 months if applicable
Proportion of subjects with on-treatment ALT flares
Measured: Through Day 90
Proportion of subjects with off-treatment ALT flares
Measured: From Day 90 through end of study, about 6 months
Rate of HBV viral load return to baseline off-treatment
Measured: From Day 90 through end of study, about 6 months
Relationship between HBV RNA and HBV Sustained Viral Response at 6 months
Measured: Through study completion, an average of 1 year, which is 6 months after treatment
Change from baseline value in HBV RNA at end of treatment and Sustained Viral Response at 6 months
Measured: Through study completion, an average of 1 year, 6 months after treatment
Change from baseline in HBsAg over time and Sustained Viral Response at 6 months
Measured: Through study completion, an average of 1 year, 6 months after treatment
Change from baseline value in HBcrAg at end of treatment and Sustained Viral Response at 6 months
Measured: Through study completion, an average of 1 year, 6 months after treatment
Relationship between HBV DNA Sustained Viral Response and HBsAg
Measured: Through study completion, an average of 1 year
Reduction from baseline in HBsAg following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year
Reduction from baseline in HBV RNA following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year
Reduction from baseline in HBcrAg following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Measured: Through study completion, an average of 1 year
Cmax of tenofovir in plasma
Measured: Through study completion, an average of 1 year
Tmax of tenofovir in plasma
Measured: Through study completion, an average of 1 year
Ctrough of tenofovir in plasma
Measured: Through study completion, an average of 1 year
Ctau of tenofovir in plasma
Measured: Through study completion, an average of 1 year
AUC0-24 of tenofovir in plasma
Measured: Through study completion, an average of 1 year
t1/2 of tenofovir in plasma
Measured: Through study completion, an average of 1 year
RAC(Cmax) of tenofovir in plasma
Measured: Through study completion, an average of 1 year
RAC(AUC) of tenofovir in plasma
Measured: Through study completion, an average of 1 year
Cmax of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
Tmax of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
Ctrough of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
Ctau of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
AUC0-24 of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
t1/2 of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
RAC(Cmax) of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
RAC(AUC) of vebicorvir in plasma
Measured: Through study completion, an average of 1 year
Correlation between individual tie to viral load relapse and Day 90 clevudine, vebicorvir, and tenofovir Cmin and AUC
Measured: Through study completion, an average of 1 year
Correlation between SVR6 and Day 90 clevudine, vebicorvir, and tenofovir Cmin and AUC
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start11 Apr 2022
- Primary completion25 May 2022
- Study completion25 May 2022
Why it stopped: Sponsor stopped due to partner collaboration ending
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antios Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238844
- Sponsor's protocol ID
- ANTT202
- Status last verified
- May 2022
- First submitted
- 13 Jan 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT05238844
- Acronym / sponsor ID
- ANTT202
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped due to partner collaboration ending
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Antios Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 14 Feb 2022 (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 randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in volunteers with chronic hepatitis B virus infection. Volunteers will be administered multiple oral doses of ATI-2173 vebicorvir in combination with tenofovir disoproxil fumarate and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATI-2173 25mg, Vebicorvir 300mg and Tenofovir 300mg | Experimental | Drug: ATI-2173 25mg, Drug: Vebicorvir 300mg, Drug: Viread 300Mg TabletSubjects randomized to active arm will receive active 25mg ATI-2173 + active Vebicorvir 300mg + active Tenofovir 300mg |
| Tenofovir Disoproxil Fumarate | Active comparator | Drug: Viread 300Mg TabletSubjects randomized to placebo arm will receive placebo 25mg ATI-2173 + placebo Vebicorvir 300mg + active Tenofovir 300mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- If female, meets one of the following criteria:
- If male, meets one of the following criteria:
- Male or female aged at least 18 years but not older than 70 years
Key exclusion criteria (30 listed)
- Female who is lactating at screening
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- History of significant hypersensitivity to clevudine, tenofovir disoproxil fumarate or any related products (including excipients of ATI-2173, tenofovir disoproxil fumarate, and the placebo) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of clinically significant muscle disorders, myopathies or other forms of liver disease
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 |
|---|---|---|
| ATI-2173 25mgATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth. | Drug | ATI-2173 25mg, Vebicorvir 300mg and Tenofovir 300mg |
| Vebicorvir 300mgVebicorvir (formerly ABI-H0731) is an orally administered, potent and selective small molecule inhibitor of the HBV core protein | Drug | ATI-2173 25mg, Vebicorvir 300mg and Tenofovir 300mg |
| Viread 300Mg TabletViread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. | Drug | ATI-2173 25mg, Vebicorvir 300mg and Tenofovir 300mg, Tenofovir Disoproxil Fumarate |
Primary outcome
The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE)
Time frame: Through study completion, an average of 1 year
The percentage of subjects who experienced at least 1 treatment-emergent serious adverse event (TE SAE)
Time frame: Through study completion, an average of 1 year
The percentage of subjects who experienced a treatment-emergent dose-limiting toxicity (TE DLT)
Time frame: Through study completion, an average of 1 year
The percentage of subjects who experienced at least 1 treatment-emergent Division of AIDS (DAIDS) Grade 1, 2, 3, 4, or 5 laboratory abnormality
Time frame: Through study completion, an average of 1 year
The percentage of subjects who discontinued the study drug due to a TEAE
Time frame: Through study completion, an average of 1 year
Alanine aminotransferase and aspartate aminotransferase levels versus time
Time frame: Through study completion, an average of 1 year
Time to HBV viral load relapse in HBV-infected subjects as measured by HBV DNA viral load in IU/mL
Time frame: Through study completion, an average of 1 year, which is 6 months after end of treatment
43 secondary outcomes
Baseline-adjusted maximal reduction in HBV DNA viral load (Emax,HBV) through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year, which is 6 months after end of treatment
TEmax,HBV through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year, which is 6 months after end of treatment
AUEC(HBV) through 6 months after end of treatment following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year, which is 6 months after end of treatment
Proportion of subjects with HBV DNA sustained viral response as measured by HBV DNA viral load at 6 months after end of treatment
Time frame: Through study completion, an average of 1 year, which is 6 months after end of treatment
Cmax of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
Tmax of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
Ctrough of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
Ctau of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
AUC0-24 of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
AUCtau of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
t1/2 of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
RAC(Cmax) of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
RAC(AUC) of ATI-2173, clevudine and M1 in plasma
Time frame: Through study completion, an average of 1 year
Proportion of subjects with HBV SVR12, SVR18, and SVR24months
Time frame: Through study completion, an average of 1 year, or through 24 months if applicable
Proportion of subjects with on-treatment ALT flares
Time frame: Through Day 90
Proportion of subjects with off-treatment ALT flares
Time frame: From Day 90 through end of study, about 6 months
Rate of HBV viral load return to baseline off-treatment
Time frame: From Day 90 through end of study, about 6 months
Relationship between HBV RNA and HBV Sustained Viral Response at 6 months
Time frame: Through study completion, an average of 1 year, which is 6 months after treatment
Change from baseline value in HBV RNA at end of treatment and Sustained Viral Response at 6 months
Time frame: Through study completion, an average of 1 year, 6 months after treatment
Change from baseline in HBsAg over time and Sustained Viral Response at 6 months
Time frame: Through study completion, an average of 1 year, 6 months after treatment
Change from baseline value in HBcrAg at end of treatment and Sustained Viral Response at 6 months
Time frame: Through study completion, an average of 1 year, 6 months after treatment
Relationship between HBV DNA Sustained Viral Response and HBsAg
Time frame: Through study completion, an average of 1 year
Reduction from baseline in HBsAg following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year
Reduction from baseline in HBV RNA following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year
Reduction from baseline in HBcrAg following ATI-2173 + vebicorvir + TDF or placebo + TDF for 90 days in HBV-infected subjects
Time frame: Through study completion, an average of 1 year
Cmax of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
Tmax of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
Ctrough of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
Ctau of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
AUC0-24 of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
t1/2 of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
RAC(Cmax) of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
RAC(AUC) of tenofovir in plasma
Time frame: Through study completion, an average of 1 year
Cmax of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
Tmax of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
Ctrough of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
Ctau of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
AUC0-24 of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
t1/2 of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
RAC(Cmax) of vebicorvir in plasma
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Sponsor stopped due to partner collaboration ending). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-2173 25mg, Vebicorvir 300mg and Viread 300Mg Tablet in people with Chronic Hepatitis b, run by Antios Therapeutics, Inc at 2 sites in 2 countries.
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 30 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: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, Ukraine. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor stopped due to partner collaboration ending). Results are not available in the source record.
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?
The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE) (time frame: Through study completion, an average of 1 year). The study lists 7 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 31 May 2022.