Chronic Hepatitis BPhase 2NCT04820686
A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection
A Phase 2 study testing VBR, AB-729 and SOC NrtI in people with Chronic Hepatitis B, run by Assembly Biosciences at 20 sites in 4 countries.
Trial summary
The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- VBR, AB-729 and SOC NrtI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 7 May 2021to 30 Mar 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)
- Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
- Chronic Hepatitis B defined as HBV infection documented for ≥6 months prior to Screening
- Hepatitis B 'e' antigen (HBeAg) negative at least 3 months prior to Screening Visit (historical documentation) AND at the Screening Visit
- Virologically suppressed on SOC NrtI therapy with nonquantifiable HBV DNA for at least 6 months prior to Screening
- On a stable SOC NrtI regimen of ETV, TDF, or TAF for >12 months
Show all 11Show fewer
- HBsAg ≥100 international units/mL at Screening
- Lack of bridging fibrosis or cirrhosis
- Agreement to comply with protocol-specified contraceptive requirements
- In good general health, except for cHBV, in the opinion of the Investigator
- Able to take oral medication and willing to receive subcutaneous injections of AB-729.
Who cannot join
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
- Females who are lactating or wish to become pregnant during the course of the study
- History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation at any time prior to, or at the time of Screening
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
- Clinically significant diseases or conditions, such as cardiac disease, including poorly-controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment; ongoing infection 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 study participation
- History of hepatocellular carcinoma (HCC)
Show all 27Show fewer
- History of malignancy other than HCC unless the subject's malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before Screening
- History or presence at Screening of electrocardiogram (ECG) abnormalities deemed clinically significant, in the opinion of the Investigator
- History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drugs
- History of any significant food or drug-related allergic reactions such as anaphylaxis or Stevens-Johnson syndrome
- Exclusionary laboratory results at Screening:
- Platelet count <100,000/mm^3
- Albumin <3 g/dL
- Direct bilirubin >1.2× upper limit of normal (ULN)
- ALT ≥5× ULN
- Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is > ULN but <100 ng/mL, the subject is eligible if hepatic imaging prior to initiation of study drug reveals no lesions indicative of possible HCC
- International Normalized Ratio (INR) >1.5× ULN
- Estimated creatinine clearance (CrCl) <50 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight at Screening
- Any other laboratory abnormality deemed clinically significant by the Investigator
- Current or prior use of prohibited (per protocol) concomitant medications from 28 days prior to Day 1.
- Current or prior treatment for cHBV with:
- Lamivudine, telbivudine or adefovir (any duration)
- HBV core inhibitor (any duration)
- siRNA or other oligonucleotide therapeutic (any duration)
- Interferon in the 6 months prior to Screening
- Any investigational agent for cHBV in the 6 months prior to Screening.
- Participation in another clinical study of a drug or device whereby the last investigational drug/device administration is within 60 days or 5 half-lives prior to study start.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Australia8 sites
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Footscray Hospital
Footscray, Victoria, 3011
Saint George Hospital - Australia
Kogarah, New South Wales, 2217
Liverpool Hospital
Liverpool, New South Wales, 2170
The Alfred Hospital
Melbourne, Victoria, 3004
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Melbourne Health
Parkville, Victoria, 3050
Westmead Hospital
Westmead, New South Wales, 2145
Canada6 sites
University Hospital - London Health Sciences Centre
London, Ontario, N6A 2C2
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Université de Québec - Université Laval
Québec, G1V 4G2
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Vancouver Infectious Disease Centre
Vancouver, British Columbia, V6Z 2C7
Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z 2K5
Bulgaria4 sites
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia-Grad, 1431
Acibadem City Clinic Tokuda Hospital
Sofia, 1407
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, 1431
Nov Rehabilitatsionen Tsentar EOOD
Stara Zagora, 6000
New Zealand2 sites
Auckland Clinical Studies
Auckland, 1010
Wellington Regional Hospital
Wellington, 6021
About this study
Official title: A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection
The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).
Read the detailed description
The initial cohort of participants will be enrolled in 3 treatment groups receiving 1) VBR + AB-729 + SOC NrtI, 2) VBR + SOC NrtI, or 3) AB-729 + SOC NrtI for up to 48 weeks. At Week 48, all participants will have an assessment of Treatment Stopping Criteria. Any participant who meets the Treatment Stopping Criteria, will discontinue their assigned treatment including NrtI and will remain in follow-up through Week 96. The participants who do not meet the Treatment Stopping Criteria will continue treatment with NrtI alone and will remain in follow-up through Week 96. Up to an additional 2 cohorts may be added to the study in future protocol amendments.
- Conditions
- Chronic Hepatitis B
- Being tested
- VBR, AB-729, SOC NrtI
- Keywords
- cHBV, HBV, hepatitis B, vebicorvir, VBR, AB-729
- 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.
VBRDrug
Also called Vebicorvir, ABI-H0731
VBR is an HBV core protein inhibitor. Participants will receive VBR 300 mg tablets orally once daily (QD).
AB-729Drug
AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants will receive a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
SOC NrtIDrug
Also called Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF)
Participants will receive their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
| Study group | Role | What they receive |
|---|---|---|
| VBR + AB-729 + SOC NrtI | Experimental | Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. Receives: Drug: VBR; Drug: AB-729; Drug: SOC NrtI |
| VBR + SOC NrtI | Other | Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen. Receives: Drug: VBR; Drug: SOC NrtI |
| AB-729 + SOC NrtI | Other | Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen. Receives: Drug: AB-729; Drug: SOC NrtI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Adverse Events (AEs)
Measured: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Number of Participants With Premature Treatment Discontinuation Due to AEs
Measured: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Number of Participants With One or More Abnormal Laboratory Result
Measured: Laboratory results were collected from the time of signing the informed consent until the study was early terminated, up to 96 weeks.
Secondary outcomes (14)
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
Number of Participants With Serum HBsAg Below the Lower Limit of Quantitation (<LLOQ)
Measured: Pre-specified time points up to 96 weeks
Number of Participants With HBV Deoxyribonucleic Acid (DNA) Not Detected (<5 IU/mL)
Measured: Week 48
Number of Participants With HBV Ribonucleic Acid (RNA) <LLOQ
Measured: Week 48
Change From Baseline in Mean log10 HBV RNA On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) On-Treatment
Measured: Baseline and Week 48
Number of Participants With HBsAg Seroconversion
Measured: Week 48
Number of Participants With Normal Alanine Aminotransferase (ALT)
Measured: Baseline and at pre-specified time points up to 96 weeks
Plasma Levels of VBR
Measured: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeks, and at Week 52
Plasma Levels of AB-729
Measured: 2 hours after dosing at pre-specified time points up to 40 weeks
Plasma Levels of SOC NrtI (ETV, TDF, TAF)
Measured: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeks
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Measured: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Measured: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Measured: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start7 May 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbutus Biopharma Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820686
- Sponsor's protocol ID
- ABI-H0731-204
- Status last verified
- Oct 2023
- First submitted
- 25 Mar 2021
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ligat G, Verrier ER, Nassal M, Baumert TF. Hepatitis B virus-host interactions and novel targets for viral cure. Curr Opin Virol. 2021 Aug;49:41-51. doi: 10.1016/j.coviro.2021.04.009. Epub 2021 May 22.
PubMed 34029994
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT04820686
- Acronym / sponsor ID
- ABI-H0731-204
- Conditions
- Chronic Hepatitis B
- Keywords
- cHBV, HBV, hepatitis B, vebicorvir, VBR, AB-729
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Arbutus Biopharma Corporation
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Posted 14 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).
Detailed description
The initial cohort of participants will be enrolled in 3 treatment groups receiving 1) VBR + AB-729 + SOC NrtI, 2) VBR + SOC NrtI, or 3) AB-729 + SOC NrtI for up to 48 weeks. At Week 48, all participants will have an assessment of Treatment Stopping Criteria. Any participant who meets the Treatment Stopping Criteria, will discontinue their assigned treatment including NrtI and will remain in follow-up through Week 96. The participants who do not meet the Treatment Stopping Criteria will continue treatment with NrtI alone and will remain in follow-up through Week 96. Up to an additional 2 cohorts may be added to the study in future protocol amendments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VBR + AB-729 + SOC NrtI | Experimental | Drug: VBR, Drug: AB-729, Drug: SOC NrtIParticipants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. |
| VBR + SOC NrtI | Other | Drug: VBR, Drug: SOC NrtIParticipants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen. |
| AB-729 + SOC NrtI | Other | Drug: AB-729, Drug: SOC NrtIParticipants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Body mass index (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)
- Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
- Chronic Hepatitis B defined as HBV infection documented for ≥6 months prior to Screening
- Hepatitis B 'e' antigen (HBeAg) negative at least 3 months prior to Screening Visit (historical documentation) AND at the Screening Visit
- Virologically suppressed on SOC NrtI therapy with nonquantifiable HBV DNA for at least 6 months prior to Screening
Key exclusion criteria (27 listed)
- Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
- Females who are lactating or wish to become pregnant during the course of the study
- History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation at any time prior to, or at the time of Screening
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
- Clinically significant diseases or conditions, such as cardiac disease, including poorly-controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment; ongoing infection 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 study participation
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 |
|---|---|---|
| VBRAlso: Vebicorvir, ABI-H0731VBR is an HBV core protein inhibitor. Participants will receive VBR 300 mg tablets orally once daily (QD). | Drug | VBR + AB-729 + SOC NrtI, VBR + SOC NrtI |
| AB-729AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants will receive a 60-mg subcutaneous injection of AB-729 once every 8 weeks. | Drug | AB-729 + SOC NrtI, VBR + AB-729 + SOC NrtI |
| SOC NrtIAlso: Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF)Participants will receive their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert. | Drug | AB-729 + SOC NrtI, VBR + AB-729 + SOC NrtI, VBR + SOC NrtI |
Primary outcome
Number of Participants With One or More Adverse Events (AEs)
Time frame: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Number of Participants With Premature Treatment Discontinuation Due to AEs
Time frame: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Number of Participants With One or More Abnormal Laboratory Result
Time frame: Laboratory results were collected from the time of signing the informed consent until the study was early terminated, up to 96 weeks.
14 secondary outcomes
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
Number of Participants With Serum HBsAg Below the Lower Limit of Quantitation (<LLOQ)
Time frame: Pre-specified time points up to 96 weeks
Number of Participants With HBV Deoxyribonucleic Acid (DNA) Not Detected (<5 IU/mL)
Time frame: Week 48
Number of Participants With HBV Ribonucleic Acid (RNA) <LLOQ
Time frame: Week 48
Change From Baseline in Mean log10 HBV RNA On-Treatment
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) On-Treatment
Time frame: Baseline and Week 48
Number of Participants With HBsAg Seroconversion
Time frame: Week 48
Number of Participants With Normal Alanine Aminotransferase (ALT)
Time frame: Baseline and at pre-specified time points up to 96 weeks
Plasma Levels of VBR
Time frame: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeks, and at Week 52
Plasma Levels of AB-729
Time frame: 2 hours after dosing at pre-specified time points up to 40 weeks
Plasma Levels of SOC NrtI (ETV, TDF, TAF)
Time frame: Before dosing at Baseline (Day 1) and at pre-specified time points up to 48 weeks
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
Time frame: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Time frame: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
Time frame: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34029994Ligat G, Verrier ER, Nassal M, Baumert TF. Hepatitis B virus-host interactions and novel targets for viral cure. Curr Opin Virol. 2021 Aug;49:41-51. doi: 10.1016/j.coviro.2021.04.009. Epub 2021 May 22.
- 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.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VBR, AB-729 and SOC NrtI in people with Chronic Hepatitis B, run by Assembly Biosciences at 20 sites in 4 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 11 inclusion and 27 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, Canada, Bulgaria, New Zealand. 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 14 Nov 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?
Number of Participants With One or More Adverse Events (AEs) (time frame: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.). The study lists 3 primary outcomes in all. 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 NCT04820686, 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 14 Nov 2023.