Chronic Hepatitis BPhase 2NCT02166047
Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants
A Phase 2 study testing Vesatolimod in people with Chronic Hepatitis B, run by Gilead Sciences at 23 sites in 6 countries.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Vesatolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 30 Jun 2014to 20 Oct 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
- Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
- Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
- Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
- Must be willing and able to comply with all study requirements
Who cannot join
- Extensive bridging fibrosis or cirrhosis
- Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
- Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
- Evidence of hepatocellular carcinoma
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
- Significant cardiovascular, pulmonary, or neurological disease
Show all 20Show fewer
- Any of the following conditions that may worsen in response to interferon (IFN):
- Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
- Poorly controlled diabetes mellitus
- Significant psychiatric disorders
- Thyroid disorder (unless controlled under treatment)
- Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
- Retinal disease
- Immunodeficiency disorders
- Received solid organ or bone marrow transplant
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
- Use of another investigational agents within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
- Females who are pregnant or may wish to become pregnant during the study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States9 sites
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02215
Study site
Detroit, Michigan, 48202
Study site
Flushing, New York, 11355
Study site
Honolulu, Hawaii, 96734
Study site
Los Angeles, California, 90095
Study site
San Diego, California, 92154
Study site
San Francisco, California, 94118
Study site
San Jose, California, 95128
Canada4 sites
Study site
Toronto, Ontario, M5G2C4
Study site
Toronto, Ontario, M5T 2S8
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Winnipeg, Manitoba, R3E 3P4
Italy4 sites
Study site
Milan, 20122
Study site
Parma, 43126
Study site
Pisa, 56124
Study site
San Giovanni Rotondo, FG, 71013
South Korea4 sites
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 138-736
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).
Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).
- Conditions
- Chronic Hepatitis B
- Being tested
- Vesatolimod, Placebo
- Keywords
- Hepatitis B, HBV, GS-9620, TLR-7 Agonist
- 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.
VesatolimodDrug
Also called GS-9620
Vesatolimod tablet administered orally
PlaceboDrug
Placebo to match vesatolimod tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo 4 Weeks (Cohort A) | Placebo comparator | Placebo tablet once a week for 4 weeks Receives: Drug: Placebo |
| Vesatolimod 1 mg 4 Weeks (Cohort A) | Experimental | Vesatolimod 1 mg tablet once a week for 4 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 2 mg 4 Weeks (Cohort A) | Experimental | Vesatolimod 2 mg tablet once a week for 4 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 4 mg 4 Weeks (Cohort A) | Experimental | Vesatolimod 4 mg tablet once a week for 4 weeks Receives: Drug: Vesatolimod |
| Placebo 8 Weeks (Cohort B) | Placebo comparator | Placebo tablet once a week for 8 weeks Receives: Drug: Placebo |
| Vesatolimod 1 mg 8 Weeks (Cohort B) | Experimental | Vesatolimod 1 mg tablet once a week for 8 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 2 mg 8 Weeks (Cohort B) | Experimental | Vesatolimod 2 mg tablet once a week for 8 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 4 mg 8 Weeks (Cohort B) | Experimental | Vesatolimod 4 mg tablet once a week for 8 weeks Receives: Drug: Vesatolimod |
| Placebo 12 Weeks (Cohort C) | Placebo comparator | Placebo tablet once a week for 12 weeks Receives: Drug: Placebo |
| Vesatolimod 1 mg 12 Weeks (Cohort C) | Experimental | Vesatolimod 1 mg tablet once a week for 12 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 2 mg 12 Weeks (Cohort C) | Experimental | Vesatolimod 2 mg tablet once a week for 12 weeks Receives: Drug: Vesatolimod |
| Vesatolimod 4 mg 12 Weeks (Cohort C) | Experimental | Vesatolimod 4 mg tablet once a week for 12 weeks Receives: Drug: Vesatolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
Measured: Baseline to Week 24
Secondary outcomes (8)
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Measured: Week 24
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Only participants who were HBeAg+ at baseline were included.
Measured: Week 48
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
Measured: Week 24
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window.
Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.
Measured: Week 48
Change From Baseline in Serum HBsAg Level at Week 4
Measured: Baseline; Week 4
Change From Baseline in Serum HBsAg Level at Week 8
Measured: Baseline; Week 8
Change From Baseline in Serum HBsAg Level at Week 12
Measured: Baseline; Week 12
Change From Baseline in Serum HBsAg Level at Week 48
Measured: Baseline; Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start30 Jun 2014
- Primary completion11 May 2016
- Study completion20 Oct 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166047
- Sponsor's protocol ID
- GS-US-283-1059
- Other IDs
- 2014-001400-22, ACTRN12614000628640, 2014
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2014
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Boni C, Vecchi A, Rossi M, Laccabue D, Giuberti T, Alfieri A, Lampertico P, Grossi G, Facchetti F, Brunetto MR, Coco B, Cavallone D, Mangia A, Santoro R, Piazzolla V, Lau A, Gaggar A, Subramanian GM, Ferrari C. TLR7 Agonist Increases Responses of Hepatitis B Virus-Specific T Cells and Natural Killer Cells in Patients With Chronic Hepatitis B Treated With Nucleos(T)Ide Analogues. Gastroenterology. 2018 May;154(6):1764-1777.e7. doi: 10.1053/j.gastro.2018.01.030. Epub 2018 Jan 31.
PubMed 29378197Janssen HLA, Brunetto MR, Kim YJ, Ferrari C, Massetto B, Nguyen AH, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Yoshida EM, Ahn SH, Tsai NCS, Fung S, Gane EJ. Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B. J Hepatol. 2018 Mar;68(3):431-440. doi: 10.1016/j.jhep.2017.10.027. Epub 2017 Dec 11.
PubMed 29104121
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02166047
- Acronym / sponsor ID
- GS-US-283-1059
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, HBV, GS-9620, TLR-7 Agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 11 May 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod in participants with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV).
Participants will be randomized in 3 sequential cohorts (Cohorts A, B, and C). Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of vesatolimod (1, 2, or 4 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Placebo 4 Weeks (Cohort A) | Placebo comparator | Drug: PlaceboPlacebo tablet once a week for 4 weeks |
| Vesatolimod 1 mg 4 Weeks (Cohort A) | Experimental | Drug: VesatolimodVesatolimod 1 mg tablet once a week for 4 weeks |
| Vesatolimod 2 mg 4 Weeks (Cohort A) | Experimental | Drug: VesatolimodVesatolimod 2 mg tablet once a week for 4 weeks |
| Vesatolimod 4 mg 4 Weeks (Cohort A) | Experimental | Drug: VesatolimodVesatolimod 4 mg tablet once a week for 4 weeks |
| Placebo 8 Weeks (Cohort B) | Placebo comparator | Drug: PlaceboPlacebo tablet once a week for 8 weeks |
| Vesatolimod 1 mg 8 Weeks (Cohort B) | Experimental | Drug: VesatolimodVesatolimod 1 mg tablet once a week for 8 weeks |
| Vesatolimod 2 mg 8 Weeks (Cohort B) | Experimental | Drug: VesatolimodVesatolimod 2 mg tablet once a week for 8 weeks |
| Vesatolimod 4 mg 8 Weeks (Cohort B) | Experimental | Drug: VesatolimodVesatolimod 4 mg tablet once a week for 8 weeks |
| Placebo 12 Weeks (Cohort C) | Placebo comparator | Drug: PlaceboPlacebo tablet once a week for 12 weeks |
| Vesatolimod 1 mg 12 Weeks (Cohort C) | Experimental | Drug: VesatolimodVesatolimod 1 mg tablet once a week for 12 weeks |
| Vesatolimod 2 mg 12 Weeks (Cohort C) | Experimental | Drug: VesatolimodVesatolimod 2 mg tablet once a week for 12 weeks |
| Vesatolimod 4 mg 12 Weeks (Cohort C) | Experimental | Drug: VesatolimodVesatolimod 4 mg tablet once a week for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
- Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
- Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
- Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
Key exclusion criteria (20 listed)
- Extensive bridging fibrosis or cirrhosis
- Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
- Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
- Evidence of hepatocellular carcinoma
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
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 |
|---|---|---|
| VesatolimodAlso: GS-9620Vesatolimod tablet administered orally | Drug | Vesatolimod 1 mg 12 Weeks (Cohort C), Vesatolimod 1 mg 4 Weeks (Cohort A), Vesatolimod 1 mg 8 Weeks (Cohort B), Vesatolimod 2 mg 12 Weeks (Cohort C), Vesatolimod 2 mg 4 Weeks (Cohort A), Vesatolimod 2 mg 8 Weeks (Cohort B), Vesatolimod 4 mg 12 Weeks (Cohort C), Vesatolimod 4 mg 4 Weeks (Cohort A), Vesatolimod 4 mg 8 Weeks (Cohort B) |
| PlaceboPlacebo to match vesatolimod tablet administered orally | Drug | Placebo 12 Weeks (Cohort C), Placebo 4 Weeks (Cohort A), Placebo 8 Weeks (Cohort B) |
Primary outcome
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24
Time frame: Baseline to Week 24
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
8 secondary outcomes
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24
Time frame: Week 24
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48
Time frame: Week 48
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Time frame: Week 24
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Time frame: Week 48
Change From Baseline in Serum HBsAg Level at Week 4
Time frame: Baseline; Week 4
Change From Baseline in Serum HBsAg Level at Week 8
Time frame: Baseline; Week 8
Change From Baseline in Serum HBsAg Level at Week 12
Time frame: Baseline; Week 12
Change From Baseline in Serum HBsAg Level at Week 48
Time frame: Baseline; Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29378197Boni C, Vecchi A, Rossi M, Laccabue D, Giuberti T, Alfieri A, Lampertico P, Grossi G, Facchetti F, Brunetto MR, Coco B, Cavallone D, Mangia A, Santoro R, Piazzolla V, Lau A, Gaggar A, Subramanian GM, Ferrari C. TLR7 Agonist Increases Responses of Hepatitis B Virus-Specific T Cells and Natural Killer Cells in Patients With Chronic Hepatitis B Treated With Nucleos(T)Ide Analogues. Gastroenterology. 2018 May;154(6):1764-1777.e7. doi: 10.1053/j.gastro.2018.01.030. Epub 2018 Jan 31.
- Results publication: PubMed 29104121Janssen HLA, Brunetto MR, Kim YJ, Ferrari C, Massetto B, Nguyen AH, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Yoshida EM, Ahn SH, Tsai NCS, Fung S, Gane EJ. Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B. J Hepatol. 2018 Mar;68(3):431-440. doi: 10.1016/j.jhep.2017.10.027. Epub 2017 Dec 11.
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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.
Gilead Study Director study director
Gilead Sciences
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vesatolimod in people with Chronic Hepatitis B, run by Gilead Sciences at 23 sites in 6 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada, Italy, South Korea, Netherlands and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 Sep 2020). 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?
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24 (time frame: Baseline to Week 24). 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 NCT02166047, which also lists 2 linked publications.
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 Oct 2020.