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Hepatitis BPhase 2B-SureNCT04954859

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

A Phase 2 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 161 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B
What is being tested?
Bepirovirsen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
161 sitesin 29 countries
Study dates
14 Dec 2021to 24 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
  • Capable of giving informed consent.
  • For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
  • Participants who have previously received at least one dose of bepirovirsen AND
  • Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR
  • Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
Show all 15Show fewer
  • For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
  • Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
  • NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml and HBV DNA <LLOQ at the EOS visit (Week 96) in the parent study OR
  • Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg <1 IU/ml and HBV DNA <LLOQ at EOS visit (Week 72) of parent study OR
  • Did not achieve NA cessation criteria in parent study but achieved at least HBsAg <1 IU/ml and HBV DNA <LLOQ at EOS visit (Week 72) of parent study.
  • For participants rolling over from 217023 (TH HBV ASO-001):
  • Participants who have previously received at least 1 dose of bepirovirsen AND
  • Achieved HBsAg <1 IU/ml and HBV DNA <LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg < 1 IU/ml and HBV DNA <LLOQ, at the EOS study visit [Week 133 ASO12 arm), or Week 145 (ASO24 arm)] in parent study OR
  • Did not achieve HBsAg <1 IU/ml and HBV DNA <LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg < 1 IU/ml and HBV DNA < LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) in the parent study.

Who cannot join

  • Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
  • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Trial locations and contacts

161 sites in 29 countries.

161 sites in 29 countries

China24 sites

  • GSK Investigational Site

    Beijing, 100015

  • GSK Investigational Site

    Beijing, 100039

  • GSK Investigational Site

    Beijing, 100050

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Chengdu, 610072

  • GSK Investigational Site

    Chongqing, 400042

  • GSK Investigational Site

    Fuzhou, 350028

  • GSK Investigational Site

    Guangzhou, 510000

  • GSK Investigational Site

    Guangzhou, 510440

  • GSK Investigational Site

    Guangzhou, 510630

  • GSK Investigational Site

    Hangzhou, 310014

  • GSK Investigational Site

    Hangzhou, 310022

  • GSK Investigational Site

    Kunming, 650021

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 201508

  • GSK Investigational Site

    Shenzhen, 518112

  • GSK Investigational Site

    Tianjin, 300000

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wuhan, 430030

  • GSK Investigational Site

    Xi'an, 710061

  • GSK Investigational Site

    Xiamen, 361015

  • GSK Investigational Site

    Zhenjiang

  • GSK Investigational Site

    Zunyi, 563114

Other trials in China

Japan16 sites

  • GSK Investigational Site

    Gifu, 500-8717

  • GSK Investigational Site

    Gifu, 503-8502

  • GSK Investigational Site

    Hiroshima, 730-8619

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Hokkaido, 006-0811

  • GSK Investigational Site

    Ishikawa, 920-8650

  • GSK Investigational Site

    Kagawa, 760-8557

  • GSK Investigational Site

    Kumamoto, 860-8556

  • GSK Investigational Site

    Kumamoto, 862-8655

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Niigata, 950-1104

  • GSK Investigational Site

    Osaka, 565-0871

  • GSK Investigational Site

    Tokyo, 113-8519

  • GSK Investigational Site

    Tokyo, 113-8603

  • GSK Investigational Site

    Tokyo, 180-8610

  • GSK Investigational Site

    Yamaguchi, 750-0061

Other trials in Japan

India10 sites

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Coimbatore, 641005

  • GSK Investigational Site

    Hyderabad

  • GSK Investigational Site

    Kanchan Bagh Hyderabad, 40000

  • GSK Investigational Site

    Mumbai, 400008

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Mumbai, 400022

  • GSK Investigational Site

    New Delhi, 110070

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Surat, 395002

Other trials in India

Taiwan8 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 824

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Tainan, 70403

  • GSK Investigational Site

    Taipei, 10002

  • GSK Investigational Site

    Taipei County, 104

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Italy7 sites

  • GSK Investigational Site

    Bergamo, 24127

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20157

  • GSK Investigational Site

    Modena, 40126

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pisa, 56124

Other trials in Italy

Russia7 sites

  • GSK Investigational Site

    Chelyabinsk, 454052

  • GSK Investigational Site

    Moscow, 121170

  • GSK Investigational Site

    Novosibirsk, 630099

  • GSK Investigational Site

    Saint Petersburg, 190103

  • GSK Investigational Site

    Saint Petersburg, 191167

  • GSK Investigational Site

    Samara, 443063

  • GSK Investigational Site

    Красноярск, 660049

Other trials in Russia

Brazil6 sites

  • GSK Investigational Site

    Aracaju, Sergipe, 49055-000

  • GSK Investigational Site

    Campinas, 13060-803

  • GSK Investigational Site

    Curitiba, 30140-073

  • GSK Investigational Site

    Manaus, 69040000

  • GSK Investigational Site

    São Paulo, 05403-000

  • GSK Investigational Site

    Vila Mariana, 04121-000

Other trials in Brazil

Bulgaria6 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Sliven, 8800

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1463

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Canada6 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Montreal, Quebec, H2X 0A9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

  • GSK Investigational Site

    Victoria, British Columbia, V8R 6R3

Other trials in Canada

France6 sites

  • GSK Investigational Site

    Clichy, 92110

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Paris

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Rennes, 35000

  • GSK Investigational Site

    Strasbourg, 67200

Other trials in France

Poland6 sites

  • GSK Investigational Site

    Gdansk, 80-405

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Łańcut, 37-100

  • GSK Investigational Site

    Lublin

  • GSK Investigational Site

    Mysłowice, 41-400

  • GSK Investigational Site

    Żychlin, 62-571

Other trials in Poland

Romania6 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 021105

  • GSK Investigational Site

    Bucharest, 030303

  • GSK Investigational Site

    Craiova Dolj, 417307

  • GSK Investigational Site

    Galati, 800179

  • GSK Investigational Site

    Oradea, 410469

Other trials in Romania

South Korea6 sites

  • GSK Investigational Site

    Ansan-si Gyenggi-do, 15355

  • GSK Investigational Site

    Busan, 47392

  • GSK Investigational Site

    Pusan, 49241

  • GSK Investigational Site

    Seoul, 03312

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 08308

Other trials in South Korea

Spain6 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    León, 24080

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Valencia, 46026

  • GSK Investigational Site

    Vigo, 36071

Other trials in Spain

United States5 sites

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Sacramento, California, 95817-1348

  • GSK Investigational Site

    San Jose, California, 95128

Other trials in United States

Argentina5 sites

  • GSK Investigational Site

    Buenos Aires, C1181ACH

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    La Plata, Buenos Aires, B1902AWL

  • GSK Investigational Site

    Rosario, 2000

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

United Kingdom5 sites

  • GSK Investigational Site

    Cottingham, North Humberside, HU16 5JQ

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    London, SW9 8RR

  • GSK Investigational Site

    London, WC1E 6JB

  • GSK Investigational Site

    Plymouth, PL68DH

Other trials in United Kingdom

Germany4 sites

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60329

  • GSK Investigational Site

    Hamburg, 20146

Other trials in Germany

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110

Other trials in Thailand

Greece3 sites

  • GSK Investigational Site

    Athens, Attica, 115 27

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Heraklion, 711 10

Other trials in Greece

Singapore3 sites

  • GSK Investigational Site

    Singapore, 119074

  • GSK Investigational Site

    Singapore, 169608

  • GSK Investigational Site

    Singapore, 529889

Other trials in Singapore

Australia2 sites

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Herston, Queensland, 4029

Other trials in Australia

Hong Kong2 sites

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Pokfulam

Other trials in Hong Kong

Philippines2 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Silang, 4118

Other trials in Philippines

South Africa2 sites

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4091

  • GSK Investigational Site

    Johannesburg, 1830

Other trials in South Africa

Hungary1 site

  • GSK Investigational Site

    Budapest, 1097

Other trials in Hungary

Malaysia1 site

  • GSK Investigational Site

    Kuala Terengganu, 20400

Other trials in Malaysia

New Zealand1 site

  • GSK Investigational Site

    Auckland, 01042

Other trials in New Zealand

Panama1 site

  • GSK Investigational Site

    Panama City, 7196

Other trials in Panama

About this study

Official title: A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear [209668: NCT04449029], B-Together [209348: NCT04676724], B-Fine [212602: NCT04544956], B-Well 1 [202009: NCT05630807], B-Well 2 [219288: NCT05630820], and TH HBV ASO-001 [217023: NCT05276297]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.

Conditions
Hepatitis B
Being tested
Bepirovirsen, Placebo
Keywords
Bepirovirsen, B-Sure, Nucleos(t)ide, Durability, HBsAg, Functional cure
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BepirovirsenDrug

    No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.

  • PlaceboDrug

    No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.

Study groups in NCT04954859
Study groupRoleWhat they receive
Not-on-NA participantsExperimentalParticipants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Receives: Drug: Bepirovirsen; Drug: Placebo
On-NA participantsExperimentalParticipants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Receives: Drug: Bepirovirsen; Drug: Placebo
NA-cessated participantsExperimentalParticipants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.
Receives: Drug: Bepirovirsen; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)

    NA indicates nucleos(t)ide analogue (NA).

    Measured: From primary endpoint assessment in the parent study up to Month 57

  2. Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882

    Measured: From Month 3 up to Month 57

  3. Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882

    Measured: From Month 3 up to Month 33

  4. Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study

    Measured: From primary endpoint assessment in the parent study up to Month 33

Secondary outcomes (24)

  1. Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have hepatitis B surface antigen (HBsAg) reversion or use of any rescue medication after NA cessation (in either parent study or study 206682)

    Measured: Up to Month 57

  2. Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have virologic relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)

    Measured: Up to Month 57

  3. Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have clinical relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)

    Measured: Up to Month 57

  4. Percentage of On-NA and NA-cessated participants with PSPO in the parent study who receive NA retreatment after NA cessation (in either parent study or study 206682)

    Measured: Up to Month 57

  5. Percentage of On-NA participants with PSPO in the parent study, who continue NA treatment in study 206882, and have no loss of treatment response

    Measured: From primary endpoint assessment in the parent study up to Month 33

  6. Percentage of Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 in absence of rescue medication after end of treatment in the parent study

    Measured: Up to Month 57

  7. Time to loss of FC from time of achieving delayed FC in Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882

    Measured: From date of achieving delayed FC up to Month 57

  8. Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have a delayed FC in 206882 in absence of rescue medication after end of treatment in the parent study

    Measured: Up to Month 57

  9. Time to loss of FC in On-NA participants who achieve a partial response in the parent study, discontinue NA treatment in study 206882 and achieve delayed FC in 206882

    Measured: From date of achieving delayed FC up to Month 57

  10. Percentage of On-NA participants with a partial response in the parent study, who do not discontinue NA treatment in study 206882, and have a delayed treatment response in 206882 in absence of rescue medication after end of treatment in the parent study

    Measured: Up to Month 33

  11. Time to loss of treatment response in On-NA participants who achieve a partial response in the parent study, do not discontinue NA treatment in study 206882 and have a delayed treatment response in 206882

    Measured: From date of achieving delayed treatment response up to Month 33

  12. Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have HBsAg loss in the absence of any rescue medication after NA cessation in 206882

    Measured: From Month 3 to Month 57

  13. Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have virologic relapse or use of any rescue medication after NA cessation in 206882

    Measured: From Month 3 up to Month 57

  14. Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have clinical relapse or use of any rescue medication after NA cessation in 206882

    Measured: From Month 3 up to Month 57

  15. Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882 and have use of any rescue medication after NA cessation in 206882

    Measured: From Month 3 up to Month 57

  16. Percentage of participants with anti-HBs (antibody to HBsAg)

    Measured: Up to 57 months

  17. Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg])

    Measured: Up to 57 months

  18. Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL])

    Measured: Up to 57 months

  19. Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL)

    Measured: Baseline (End of Study visit in the parent study) and up to 57 months

  20. Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL])

    Measured: Up to 57 months

  21. Change from Baseline for HBcrAg (kU/mL)

    Measured: Baseline (End of Study visit in the parent study) and up to 57 months

  22. Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)

    Measured: Up to 57 months

  23. Change from Baseline for HBV RNA (log10 IU/ml)

    Measured: Baseline (End of Study visit in the parent study) and up to 57 months

  24. Percentage of participants with mutations

    Measured: Up to 57 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start14 Dec 2021
  3. Primary completion24 Jan 2029 (estimated)
  4. Study completion24 Jan 2029 (estimated)

Resources

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
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04954859
Sponsor's protocol ID
206882
Other IDs
2023-506867-33, 2021-000554-26, 2023-506867-33-01, 2023
Acronym
B-Sure
Status last verified
Nov 2026
First submitted
29 Jun 2021
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline at 161 sites in 29 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 15 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in China, Japan, India, Taiwan, Italy and 24 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO) (time frame: From primary endpoint assessment in the parent study up to Month 57). The study lists 4 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 NCT04954859.

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 5 Nov 2026.

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