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Hepatitis B, ChronicPhase 1NCT02952924

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

A Phase 1 study testing Midazolam and RO7049389 in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 21 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Midazolam and RO7049389
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
192 participants
Where
21 sitesin 8 countries
Study dates
14 Dec 2016to 16 Mar 2022
Phase
Phase 1
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part 1- Healthy Volunteers only:
  • Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead Electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • A Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive
  • Female participants must be either surgically sterile or post-menopausal for at least one year
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
  • Part 2- Chronic HBV-infected participants only:
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  • A BMI between 18 to 30 kg/m^2 inclusive
  • Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization
  • HBV DNA at screening greater than or equal to (>/=) 2 × 10^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or >/=2 × 10^3 IU/mL for HBeAg-negative participants
  • Liver biopsy, fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
  • For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods that result in a failure rate of less than (<)1 percent (%) per year during the treatment period and for at least 3 months after the last dose of study drug
  • Part 3- Chronic HBV Participants Only:
  • A BMI between 18 to 32 kg/m^2 inclusive
  • Chronic hepatitis B infection, defined as positive test for HBsAg or HBV DNA, or positive HBeAg, for more than 6 months prior to screening
  • For Cohorts only enrolling NUC-suppressed CHB participants (e.g. POM Cohort A), participants must have been treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for at least 12 months. Participants must be on the same NUC therapy for at least 3 months prior to screening
  • For Cohorts only enrolling anti-HBV treatment-naive and immune-active participants (e.g. POM Cohort B and Cohort C), previous anti-HBV treatments <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose
  • Liver biopsy, fibroscan, or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis
  • For men: agreement to remain abstinent or use contraceptive measures, and agree to refrain from donating sperm
  • For women of childbearing potential: agreement to remain abstinent or to use two approved contraceptive methods during the study and for at least 6 months after the last dose of study drug

Who cannot join

  • Part 1- Healthy Volunteers only:
  • History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
  • History of Gilbert's syndrome
  • Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration
  • Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies
  • Any clinically significant concomitant diseases or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
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  • Positive test at screening of any of the following: Hepatitis A (HAV IgM Ab), Hepatitis B (HBsAg), Hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus (HIV Ab)
  • Acute narrow-angle glaucoma (for MAD-midazolam cohorts)
  • Part 2- Chronic HBV-infected participants only:
  • History or other evidence of bleeding from esophageal varices
  • Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy
  • History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steatohepatitis, etc.)
  • Documented history or other evidence of metabolic liver disease within one year of randomization
  • Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, or human immunodeficiency virus
  • History of or suspicion of hepatocellular carcinoma or alphafetoprotein >/= Upper limit of normal (ULN) at screening
  • History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease
  • History of organ transplantation
  • Previous or concurrent HBV treatments in the past 6 months
  • Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization
  • Part 3- Chronic Hepatitis B Participants Only:
  • History or other evidence of bleeding from esophageal varices
  • Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, or hepatic encephalopathy
  • History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic statohepatitis, etc.)
  • History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests
  • Documented history or other evidence of metabolic liver disease within one year of screening
  • Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, HEV, or HIV
  • Diagnosed or suspected hepatocellular carcinoma
  • History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric, or neurological disease
  • History of organ transplantation
  • Significant acute infection (e.g. influenza, local infection) or any other clinically significant illness within 2 weeks of screening

Trial locations and contacts

21 sites in 8 countries.

21 sites in 8 countries

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City

  • Taichung Veterans Gen Hosp

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70457

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital - Linkou Branch

    Taipei

Other trials in Taiwan

China3 sites

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

    Shanghai, 200025

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040

Other trials in China

Thailand3 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

Australia2 sites

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Hong Kong2 sites

  • The University of Hong Kong; Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

New Zealand2 sites

  • Middlemore Hospital

    Auckland

  • Auckland Clinical Studies Limited

    Grafton, 1010

Other trials in New Zealand

Singapore2 sites

  • National University Health System

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

Bulgaria1 site

  • Acibadem City Clinic Tokuda Hospital Ead

    Sofia, 1407

Other trials in Bulgaria

About this study

Official title: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of ro7049389 in: (1) Single- (With or Without Food) and Multiple- (With Midazolam) Ascending Doses in Healthy Volunteers; (2) Patients Chronically Infected With Hepatitis b Virus (3) Patients With Chronic Hepatitis B.

This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label part to assess the efficacy and safety of RO7049389 when administered in combination with standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and treatment-naive chronic hepatitis B (CHB) participants.

Being tested
Midazolam, Placebo, RO7049389
Medical subject headings
Hepatitis B, Chronic

What participants receive

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

  • MidazolamDrug

    Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo

  • PlaceboOther

    Placebo matching to RO7049389 will be administered as per schedule described in individual arm.

  • RO7049389Drug

    RO7049389 will be administered as per schedule described in individual arm.

Study groups in NCT02952924
Study groupRoleWhat they receive
Parts 1a and 1b: SAD in Healthy Volunteers (Placebo)Placebo comparatorIn Part 1a, participants will receive a single oral dose of placebo matching to RO7049389 film coated tablet on Day 1. In Part 1b, minimum 8 participants from Part 1a will be selected and 2 of whom will receive another single dose of placebo matching to RO7049389 on Day 16 after eating the standard United States - Food and Drug Administration (US FDA)-recommended high-fat and high-calorie breakfast.
Receives: Other: Placebo
Parts 1a and 1b: SAD in Healthy Volunteers (RO7049389)ExperimentalIn Part 1a, participants will receive a single oral dose of RO7049389 film coated tablet on Day 1 in dose-escalation cohorts with a starting dose of 150 milligrams (mg). The doses for subsequent cohorts will be defined by an adaptive approach based on the safety and PK data in previously-dosed healthy volunteers. In Part 1b, minimum 8 participants from Part 1a will be selected and 6 of whom will receive another single dose of RO7049389 on Day 16 after eating the standard US FDA-recommended high-fat and high-calorie breakfast.
Receives: Drug: RO7049389
Part 1c: MAD in Healthy Volunteers (Placebo)Placebo comparatorParticipants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 13 (either once a day [QD] or twice a day [BID]) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 micrograms [mcg]) on Day -1 and Day 14.
Receives: Drug: Midazolam; Other: Placebo
Part 1c: MAD in Healthy Volunteers (RO7049389)ExperimentalParticipants will receive RO7049389 film coated tablet from Days 1 to 13 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 mcg) on Day -1 and Day 14.
Receives: Drug: Midazolam; Drug: RO7049389
Part 2: POM in Chronic HBV Participants (Placebo)Placebo comparatorParticipants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 27 (either QD or BID) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 28.
Receives: Other: Placebo
Part 2: POM in Chronic HBV Participants (RO7049389)ExperimentalParticipants will receive RO7049389 film coated tablet from Days 1 to 27 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 28.
Receives: Drug: RO7049389
Part 3: POM in NUC-Suppressed CHB Participants (Cohort A)ExperimentalParticipants will receive RO7049389 on top of a NUC for 48 weeks at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines.
Receives: Drug: RO7049389
Part 3: POM in Treatment-Naive CHB Participants (Cohort B)ExperimentalParticipants will receive RO7049389 for 4 weeks, followed by RO7049389 with an added NUC for 44 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines.
Receives: Drug: RO7049389
Part 3: POM in Treatment-Naive CHB Participants (Cohort C)ExperimentalParticipants will receive RO7049389 + NUC + Pegylated-Interferon (Peg-IFN) for 48 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC and Peg-IFN therapy will be administered per local label or guidelines.
Receives: Drug: RO7049389

What is being measured

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

  1. Part 1: Percentage of Participants With Adverse Events

    Measured: Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c)

  2. Parts 1a and 1b: SAD Cohort: Time to Reach Maximum Concentration (Tmax) of RO7049389

    Measured: Up to 28 days

  3. Parts 1a and 1b: SAD Cohort: Maximum Observed Plasma Concentration (Cmax) of RO7049389

    Measured: Up to 28 days

  4. Parts 1a and 1b: SAD Cohort: AUC From Time Zero to Infinity (AUC0-inf) of RO7049389

    Measured: Up to 28 days

  5. Parts 1a and 1b: SAD Cohort: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of RO7049389

    Measured: Up to 28 days

  6. Parts 1a and 1b: SAD Cohort: Half-life (T1/2) of RO7049389

    Measured: Up to Day 28

  7. Parts 1a and 1b: SAD Cohort: Apparent Oral Clearance (CL/F) of RO7049389

    Measured: Up to Day 28

  8. Parts 1a and 1b: SAD Cohort: Cumulative Amount Excreted Unchanged in Urine (Ae) of RO7049389

    Measured: Up to Day 28

  9. Parts 1a and 1b: SAD Cohort: Renal Clearance (CLr) of RO7049389

    Measured: Up to Day 28

  10. Part 2: Percentage of Participants With Adverse Events

    Measured: Up to Day 112

  11. Part 2: Quantitative Plasma HBV DNA Level

    Measured: Baseline - Day 112

  12. Part 3: Proportion of Patients Achieving Functional Cure

    Functional cure is defined as HBV DNA < lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-treatment.

    Measured: Every 2-4 weeks from Baseline through Week 72

Secondary outcomes (32)

  1. Part 1b: Food Effect on Cmax of RO7049389

    This outcome measure evaluated the effect of food on the pharmacokinetics (PK) of RO7049389 after the administration of a single dose. Participants were fed a high-fat, high-calorie breakfast (per FDA food effect bioavailability and bioequivalence study recommendations) 30 minutes prior to dosing after fasting overnight for at least 8 hours. ANOVA (factors fasted/fed state and subject) was performed for measurements available in subjects in both fasted and fed states.

    Measured: Day 16

  2. Part 1b: Food Effect on AUCinf of RO7049389

    This outcome measure evaluated the effect of food on the pharmacokinetics (PK) of RO7049389 after the administration of a single dose. Participants were fed a high-fat, high-calorie breakfast (per FDA food effect bioavailability and bioequivalence study recommendations) 30 minutes prior to dosing after fasting overnight for at least 8 hours. ANOVA (factors fasted/fed state and subject) was performed for measurements available in subjects in both fasted and fed states.

    Measured: Day 16

  3. Part 1c: Cmax of Midazolam

    This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).

    Measured: Up to Day 14

  4. Part 1c: AUCinf of Midazolam

    This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).

    Measured: Up to Day 14

  5. Part 1c: Tmax of RO7049389

    Measured: Up to Day 14

  6. Part 1c: Cmax of RO7049389

    Measured: Up to Day 14

  7. Part 1c: AUC0-12hr of RO7049389

    Measured: Up to Day 14

  8. Part 1c: CLr of RO7049389

    Measured: Up to Day 14

  9. Part 1c: Accumulation Ratio of RO7049389

    This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 14) within each arm.

    Measured: Day 1, Day 14

  10. Part 1c: T1/2 of RO7049389

    Measured: Up to Day 14

  11. Part 1c: Ae of RO7049389

    Measured: Up to Day 14

  12. Part 1c: Ctrough of RO7049389

    Measured: Up to Day 14

  13. Part 2: HBV DNA < Lower Limit of Quantification (LLOQ)

    Measured: Baseline - Day 112/Follow-up Day 84

  14. Part 2: Tmax of RO7049389

    Measured: Up to Day 28

  15. Part 2: Cmax of RO7049389

    Measured: Up to Day 28

  16. Part 2: AUCtau of RO7049389

    Measured: Up to Day 28

  17. Part 2: Accumulation Ratio of RO7049389

    This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 28) within each arm.

    Measured: Day 1, Day 28

  18. Part 2: T1/2 of RO7049389

    Measured: Up to Day 28

  19. Part 2: Ctrough of RO7049389

    Measured: Up to Day 28

  20. Part 3: Percentage of Participants With AEs

    Measured: 72 weeks

  21. Part 3: Hepatitis B Surface Antigen (HBsAg) Level

    Measured: Baseline - Week 72

  22. Part 3: Hepatitis B e-Antigen (HBeAg) Levels

    Measured: Baseline - Week 72

  23. Part 3: HBV RNA Level

    Measured: Baseline - Week 72

  24. Part 3: HBV Core-Related Antigen (HBcrAg) Levels

    Measured: Baseline - Week 72

  25. Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation

    Measured: Week 12 - Week 72

  26. Part 3: Percentage of Participants With Anti-Hepatitis B Core Antigen (HBc) Antibodies

    Measured: Up to Week 72

  27. Part 3: HBV DNA Level

    Measured: Baseline - Week 72

  28. Part 3: HBV DNA < Lower Limit of Quantification (LLOQ)

    Measured: Baseline - Week 72

  29. Part 3: Tmax of RO7049389

    Measured: Day 1 - Week 48

  30. Part 3: Cmax of RO7049389

    Measured: Day 1 - Week 48

  31. Part 3: AUCtau of RO7049389

    Measured: Day 1 - Week 48

  32. Part 3: T1/2 of RO7049389

    Measured: Day 1 - Week 48

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study start14 Dec 2016
  3. Primary completion16 Mar 2022
  4. Study completion16 Mar 2022

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952924
Sponsor's protocol ID
YP39364
Status last verified
Aug 2024
First submitted
1 Nov 2016
Last updated
31 Oct 2024

Publications

  • Yuen MF, Zhou X, Gane E, Schwabe C, Tanwandee T, Feng S, Jin Y, Triyatni M, Lemenuel-Diot A, Cosson V, Xue Z, Kazma R, Bo Q. Safety, pharmacokinetics, and antiviral activity of RO7049389, a core protein allosteric modulator, in patients with chronic hepatitis B virus infection: a multicentre, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):723-732. doi: 10.1016/S2468-1253(21)00176-X. Epub 2021 Jul 6.

    PubMed 34237271

  • Feng S, Gane E, Schwabe C, Zhu M, Triyatni M, Zhou J, Bo Q, Jin Y. A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e01323-20. doi: 10.1128/AAC.01323-20. Print 2020 Oct 20.

    PubMed 32839221

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam and RO7049389 in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 21 sites in 8 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 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Taiwan, China, Thailand, Australia, Hong Kong and 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 31 Oct 2024). 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?

Part 1: Percentage of Participants With Adverse Events (time frame: Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c)). The study lists 12 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 NCT02952924, 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 31 Oct 2024.

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