Papillomavirus InfectionsPhase 3NCT05285826
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
A Phase 3 study testing 9vHPV Vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 34 sites in China.
Trial summary
This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- 9vHPV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,100 participants
- Where
- 34 sitesChina
- Study dates
- 18 Feb 2022to 25 May 2029
- Phase
- Phase 3
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a Chinese male.
- Has no more than 5 lifetime sexual partners.
Who cannot join
- Has a history of known prior vaccination with an HPV vaccine.
- Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
- Has a history of severe allergic reaction that required medical intervention.
- Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study.
- Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
- Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Beijing Youan Hospital ( Site 0001)
Beijing, Beijing Municipality, 100069
Hunan Provincial Center for Disease Control and Prevention ( Site 0040)
Changsha, Hunan, 410005
The Third Xiangya Hospital of Central South University ( Site 0033)
Changsha, Hunan, 410013
The Second Affiliated Hospital Chongqing Medical University ( Site 0052)
Chongqing, Chongqing Municipality, 400010
Chongqing Public Health Medical Center ( Site 0003)
Chongqing, Chongqing Municipality, 400036
Binchuan County Center for Disease Control and Prevention ( Site 0022)
Dali, Yunnan, 671600
Xiangyun County Center for Disease Control and Prevention ( Site 0021)
Dali, Yunnan, 672100
Dazhu Disease Prevention and Control Center ( Site 0010)
Dazhou, Sichuan, 635100
Yuechi Disease Prevention and Control Center ( Site 0009)
Guang’an, Sichuan, 638399
Southern Medical University Nanfang Hospital-Center for Drug Clinical Research ( Site 0031)
Guangzhou, Guangdong, 510515
First Affiliated Hospital of Kunming Medical University ( Site 0051)
Kunming, Yunnan, 650032
Yunnan Provincial Infectious Disease Hospital ( Site 0042)
Kunming, Yunnan, 650111
The First Hospital of Lanzhou University ( Site 0034)
Lanzhou, Gansu, 730000
Center for Disease Control and Prevention of Rong An ( Site 0046)
Liuzhou, Guangxi, 545400
Liucheng County Centers for Disease Control and Prevention ( Site 0045)
Liuzhou, Guangxi
Loudi Disease Prevention and Control Center Zhiyebing Prevention And Treatment Hospital ( Site 0015)
Louxing District, Hunan, 417000
Mianyang Center for Disease Control and Prevention ( Site 0007)
Mianyang, Sichuan, 621000
Santai County Center for Disease Control and Prevention ( Site 0008)
Mianyang, Sichuan, 621100
The Second Hospital of Nanjing (Tangshan Branch) ( Site 0028)
Nanjing, Jiangsu, 2100003
Neijiang Center for Disease Control and Prevention ( Site 0011)
Neijiang, Sichuan, 641000
The first affiliated hospital of China medical university ( Site 0041)
Shenyang, Liaoning, 110001
Liaoning University of Traditional Chinese Medicine Affiliated Hospital ( Site 0048)
Shenyang, Liaoning, 110031
The University of Hong Kong - Shenzhen Hospital ( Site 0049)
Shenzhen, Guangdong, 518053
Tianjin Second People's Hospital ( Site 0004)
Tianjin, Tianjin Municipality, 300192
Tianjin People' s Hospital ( Site 0038)
Tianjin, Tianjin Municipality
Zhejiang University School of Medicine - Affiliated Wenzhou Traditional Chinese Medicine Hospital (W
Wenzhou, Zhejiang, 325000
Wuhan Union Hospital ( Site 0032)
Wuhan, Hubei, 430022
Xiangtan Disease Prevention and Control Center ( Site 0030)
Xiangtan, Hunan
Xiangxiang Disease Prevention and Control Center ( Site 0016)
Xiangxiang, Hunan
Qiyang Center for Disease Control and Prevention ( Site 0014)
Yongzhou, Hunan, 426100
Yuanqu Center for Disease Control and Prevention ( Site 0019)
Yuncheng, Shanxi, 043700
Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0018)
Yuncheng, Shanxi, 044000
Yongji Center for Disease Control and Prevention ( Site 0026)
Yuncheng, Shanxi, 044599
Ruicheng Center for Disease Control and Prevention ( Site 0025)
Yuncheng, Shanxi, 044600
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age
This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
- Conditions
- Papillomavirus Infections
- Being tested
- 9vHPV Vaccine, Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9vHPV VaccineBiological
Also called V503
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection
PlaceboOther
Sterile saline solution administered as a 0.5 mL IM injection
| Study group | Role | What they receive |
|---|---|---|
| V503 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. Receives: Biological: 9vHPV Vaccine |
| Placebo | Placebo comparator | Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 12-month Persistent Infection
This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 3 or more consecutive visits over a period of at least 12 months.
Measured: Up to approximately 30 months
Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Genital Warts, PIN, or Penile/Perianal/Perineal Cancer
This endpoint is defined as having occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of genital warts, PIN of any grade, or penile/perianal/perineal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.
Measured: Up to approximately 78 months
Secondary outcomes (8)
Stage 1: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 6-month Persistent Infection
This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 2 or more consecutive visits over a period of at least 6 months.
Measured: Up to approximately 30 months
Stage 1: Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at One Month Post-Dose 3
GMTs to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a Competitive Luminex Immunoassay (cLIA).
Measured: Month 7
Stage 1: Percentage of Participants Achieving Seroconversion to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58 at One Month Post-Dose 3
A participant who changes serostatus from seronegative at Day 1 to seropositive at one month post-Dose 3 for a given HPV type is considered to have achieved seroconversion for that type. A participant with a titer at or above the seropositivity cutoff for a given HPV type, as measured by cLIA, is considered seropositive for that type.
Measured: Month 7
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded.
Measured: Day 1 through Day 8 following any vaccination
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.
Measured: Day 1 through Day 8 following any vaccination
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Measured: Up to approximately 30 months
Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Anal Intraepithelial Neoplasia (AIN) or Anal Cancer (MSM participants only)
This endpoint is defined to have occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of AIN of any grade or anal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.
Measured: Up to approximately 78 months
Stages I and II: Percentage of Participants Who Experience at Least 1 SAE
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Measured: Up to approximately 78 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start18 Feb 2022
- Primary completion25 May 2029 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285826
- Sponsor's protocol ID
- V503-052
- Status last verified
- Dec 2024
- First submitted
- 8 Mar 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy, Immunogenicity, and Safety of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine, in Chinese Males 20 to 45 Years of Age
- ClinicalTrials.gov ID
- NCT05285826
- Acronym / sponsor ID
- V503-052
- Conditions
- Papillomavirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,100 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 25 May 2029 (estimated)
- Study completion
- 25 May 2029 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, immunogenicity, and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese men 20 to 45 years of age. It will enroll heterosexual men (HM) and men who have sex with men (MSM), will be stratified by age and sexual orientation, and will have two stages. The primary hypothesis of Stage I is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related external genital and intra-anal 12-month persistent infection (PI) compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative from Day 1 through one month post-Dose 3 to the relevant HPV type. The primary hypothesis of Stages I and II combined is: 9vHPV vaccine reduces the combined incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), or penile/perianal/perineal cancer compared with placebo in males 20 to 45 years of age who are seronegative at Day 1 and PCR negative from Day 1 through one month post-Dose 3 to the relevant HPV type.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V503 | Experimental | Biological: 9vHPV VaccineParticipants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is a Chinese male.
- Has no more than 5 lifetime sexual partners.
Key exclusion criteria (7 listed)
- Has a history of known prior vaccination with an HPV vaccine.
- Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
- Has a history of severe allergic reaction that required medical intervention.
- Has received immune globulin or blood-derived products in the past 3 months or plans to receive any before Month 7 of the study.
- Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
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 |
|---|---|---|
| 9vHPV VaccineAlso: V5039-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) L1 virus-like particle vaccine administered as a 0.5-mL IM injection | Biological | V503 |
| PlaceboSterile saline solution administered as a 0.5 mL IM injection | Other | Placebo |
Primary outcome
Stage I: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 12-month Persistent Infection
Time frame: Up to approximately 30 months
This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 3 or more consecutive visits over a period of at least 12 months.
Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Genital Warts, PIN, or Penile/Perianal/Perineal Cancer
Time frame: Up to approximately 78 months
This endpoint is defined as having occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of genital warts, PIN of any grade, or penile/perianal/perineal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.
8 secondary outcomes
Stage 1: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 6-month Persistent Infection
Time frame: Up to approximately 30 months
Stage 1: Geometric Mean Titers (GMTs) to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at One Month Post-Dose 3
Time frame: Month 7
Stage 1: Percentage of Participants Achieving Seroconversion to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58 at One Month Post-Dose 3
Time frame: Month 7
Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event (AE)
Time frame: Day 1 through Day 8 following any vaccination
Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic AE
Time frame: Day 1 through Day 8 following any vaccination
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Time frame: Up to approximately 30 months
Stages I and II: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related Anal Intraepithelial Neoplasia (AIN) or Anal Cancer (MSM participants only)
Time frame: Up to approximately 78 months
Stages I and II: Percentage of Participants Who Experience at Least 1 SAE
Time frame: Up to approximately 78 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 9vHPV Vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 34 sites in China.
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 2 inclusion and 7 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Stage I: Combined Incidence of HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, and 58-related External Genital and Intra-anal 12-month Persistent Infection (time frame: Up to approximately 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.