Chronic Hepatitis BPhase 2NCT03780543
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
A Phase 2 study of Chronic Hepatitis B, run by Assembly Biosciences at 24 sites in 5 countries.
Trial summary
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Chronic Hepatitis B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 20 Dec 2018to 26 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent.
- Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202 (NCT03577171) and completed the treatment period, with demonstrated compliance in the opinion of the investigator.
- Female subjects must agree to use an effective birth control method for the duration of the study and follow-up, or be surgically sterile for at least 6 months, or at least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels consistent with a postmenopausal status. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of childbearing potential must have a negative serum pregnancy test.
- All heterosexually active male subjects must agree to use an effective birth control method for the duration of the study and follow-up. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, hormone-based contraception (only female partner of a male subject), IUD, diaphragm, or cervical cap.
- Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or other substances, or unnecessary over-the-counter medications throughout study duration.
- In good general health except for chronic HBV infection.
- Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211 regimen in the opinion of the Investigator.
Who cannot join
- Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of compliance on a previous study of ABI H0731.
- Must not have had a treatment-emergent adverse event or laboratory abnormalities deemed clinically significant and possibly or probably related to drug while on a previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for this study.
- Current clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for the study.
- Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States17 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Digestive Disease Associates
Catonsville, Maryland, 21228
Southern California Research Center
Coronado, California, 92118
Sing Chan, MD
Flushing, New York, 11355
Infectious Disease Care
Hillsborough, New Jersey, 08844
Coalition of Inclusive Medicine
Los Angeles, California, 90057
University of California Los Angeles
Los Angeles, California, 90095
University of Miami Hospital and Clinics
Miami, Florida, 33136
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Xiaoli Ma, MD
Philadelphia, Pennsylvania, 19107
Research and Education
San Diego, California, 92115
Medical Associates Research Group
San Diego, California, 92123
Quest Clinical Research
San Francisco, California, 94115
Stanford University Medical Center
Stanford, California, 94305
Canada3 sites
Toronto Liver Center
Toronto, Ontario, M6H 3M1
Toronto General Hospital
Toronto, Ontario
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
New Zealand2 sites
Auckland Clinical Studies
Auckland
Waikato Hospital
Hamilton
About this study
Official title: A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
Read the detailed description
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to 100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect on biomarkers of sustained viral response (SVR) (NCT03780543).
- Conditions
- Chronic Hepatitis B
- Being tested
- standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
- Keywords
- CHB (chronic hepatitis B infection), HBV (hepatitis B virus), HBeAg positive (hepatitis B "e" antigen - positive), HBeAg negative (hepatitis B "e" antigen - negative), Hepatitis B (hepatitis B virus), Hepatitis B virus (HBV), SVR (sustained viral response)
- 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.
standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)Drug
Also called Entecavir (ETV) - brand name Baraclude, Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread, Tenofovir Alafenamide (TAF) - brand name: Descovy
Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert.
| Study group | Role | What they receive |
|---|---|---|
| HBeAg-negative Subjects from Parent Study ABI-H0731-201 | Active comparator | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care (SOC) nucleos(t)ide (NrtI)-suppressed and HBeAg-negative will receive both ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years. Receives: Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) |
| HBeAg-positive Subjects from Parent Study ABI-H0731-201 | Active comparator | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
1. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years.
2. Subjects with insufficient virologic response will discontinue ABI-H0731 only and continue on SOC NrtI alone and followed-up for 12 weeks. Receives: Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) |
| Subjects from Parent Study ABI-H0731-202 | Active comparator | Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
1. Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148.
Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up for up to 3 years. Subjects with insufficient virologic response at Week 148, will discontinue ABI-H0731 only and continue on SOC NrtI alone for up to 12 weeks.
2. Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731only and continue on SOC NrtI alone and enter follow-up for up to 12 weeks. Receives: Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR) at 24 Weeks Off Treatment
To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.
SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.
Measured: Completing from week 52 until week 76
Secondary outcomes (4)
Number of Subjects With Adverse Events
Incidence of treatment emergent adverse events (AEs)
Measured: Up to Week 148
Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)
To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS
Measured: EOT: up to Week 52 or 148; EOS: up to 3 years off treatment
Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
Incidence of subjects with suppression/loss of viral Hepatitis B "e" antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy
Measured: upto Week 148
Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment
Measured: Up to Week 148
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Dec 2018
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Anderson, Study director, Assembly Biosciences Inc.M. F. Yuen, MD, PhD, DSc, Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780543
- Sponsor's protocol ID
- ABI-H0731-211
- Other IDs
- NCT03780543
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2018
- Last updated
- 19 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuen MF, Fung S, Ma X, Nguyen TT, Hassanein T, Hann HW, Elkhashab M, Nahass RG, Park JS, Jacobson IM, Ayoub WS, Han SH, Gane EJ, Zomorodi K, Yan R, Ma J, Knox SJ, Stamm LM, Bonacini M, Weilert F, Ramji A, Bennett M, Ravendhran N, Chan S, Dieterich DT, Kwo PY, Schiff ER, Bae HS, Lalezari J, Agarwal K, Sulkowski MS. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses. JHEP Rep. 2024 Jan 18;6(4):100999. doi: 10.1016/j.jhepr.2023.100999. eCollection 2024 Apr.
PubMed 38510983
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT03780543
- Acronym / sponsor ID
- ABI-H0731-211
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB (chronic hepatitis B infection), HBV (hepatitis B virus), HBeAg positive (hepatitis B "e" antigen - positive), HBeAg negative (hepatitis B "e" antigen - negative), Hepatitis B (hepatitis B virus), Hepatitis B virus (HBV), SVR (sustained viral response)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
Detailed description
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to 100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect on biomarkers of sustained viral response (SVR) (NCT03780543).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBeAg-negative Subjects from Parent Study ABI-H0731-201 | Active comparator | Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care (SOC) nucleos(t)ide (NrtI)-suppressed and HBeAg-negative will receive both ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years. |
| HBeAg-positive Subjects from Parent Study ABI-H0731-201 | Active comparator | Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. 1. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years. 2. Subjects with insufficient virologic response will discontinue ABI-H0731 only and continue on SOC NrtI alone and followed-up for 12 weeks. |
| Subjects from Parent Study ABI-H0731-202 | Active comparator | Drug: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. 1. Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up for up to 3 years. Subjects with insufficient virologic response at Week 148, will discontinue ABI-H0731 only and continue on SOC NrtI alone for up to 12 weeks. 2. Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731only and continue on SOC NrtI alone and enter follow-up for up to 12 weeks. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent.
- Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202 (NCT03577171) and completed the treatment period, with demonstrated compliance in the opinion of the investigator.
- Female subjects must agree to use an effective birth control method for the duration of the study and follow-up, or be surgically sterile for at least 6 months, or at least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels consistent with a postmenopausal status. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of childbearing potential must have a negative serum pregnancy test.
- All heterosexually active male subjects must agree to use an effective birth control method for the duration of the study and follow-up. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, hormone-based contraception (only female partner of a male subject), IUD, diaphragm, or cervical cap.
- Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or other substances, or unnecessary over-the-counter medications throughout study duration.
Key exclusion criteria (4 listed)
- Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of compliance on a previous study of ABI H0731.
- Must not have had a treatment-emergent adverse event or laboratory abnormalities deemed clinically significant and possibly or probably related to drug while on a previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for this study.
- Current clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for the study.
- Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study.
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 |
|---|---|---|
| standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)Also: Entecavir (ETV) - brand name Baraclude, Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread, Tenofovir Alafenamide (TAF) - brand name: DescovyParticipants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert. | Drug | HBeAg-negative Subjects from Parent Study ABI-H0731-201, HBeAg-positive Subjects from Parent Study ABI-H0731-201, Subjects from Parent Study ABI-H0731-202 |
Primary outcome
Sustained Viral Response (SVR) at 24 Weeks Off Treatment
Time frame: Completing from week 52 until week 76
To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy. SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.
4 secondary outcomes
Number of Subjects With Adverse Events
Time frame: Up to Week 148
Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
Time frame: EOT: up to Week 52 or 148; EOS: up to 3 years off treatment
Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
Time frame: upto Week 148
Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
Time frame: Up to Week 148
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38510983Yuen MF, Fung S, Ma X, Nguyen TT, Hassanein T, Hann HW, Elkhashab M, Nahass RG, Park JS, Jacobson IM, Ayoub WS, Han SH, Gane EJ, Zomorodi K, Yan R, Ma J, Knox SJ, Stamm LM, Bonacini M, Weilert F, Ramji A, Bennett M, Ravendhran N, Chan S, Dieterich DT, Kwo PY, Schiff ER, Bae HS, Lalezari J, Agarwal K, Sulkowski MS. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses. JHEP Rep. 2024 Jan 18;6(4):100999. doi: 10.1016/j.jhepr.2023.100999. eCollection 2024 Apr.
- 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.
Michele Anderson study director
Assembly Biosciences Inc.
M. F. Yuen, MD, PhD, DSc study chair
The University of Hong Kong
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Chronic Hepatitis B, run by Assembly Biosciences at 24 sites in 5 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 7 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: stopped early, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, New Zealand, Hong Kong, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Viral Response (SVR) at 24 Weeks Off Treatment (time frame: Completing from week 52 until week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780543, which also lists 1 linked publication.
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 Apr 2023.