Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationPhase 3KHDT-SGTNCT06760065
Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment
A Phase 3 study testing Keverprazan Hydrochloride tablets + high dose amoxicillin and Susceptibility-Guided Quadruple Therapy in people with Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This study aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
- What is being tested?
- Keverprazan Hydrochloride tablets + high dose amoxicillin and Susceptibility-Guided Quadruple Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 31 Dec 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged ≥18 years and ≤75 years at the time of signing the informed consent.
- Participants who have undergone at least one prior standard H. pylori eradication treatment but failed.
- Current H. pylori infection confirmed by 13C-UBT, or H. pylori culture.
- Participants who, in the investigator's opinion, are able to understand and comply with the study requirements.
- Written informed consent and any required privacy authorization documents signed and dated before the initiation of any study procedures.
- For women of childbearing potential with regular or potential sexual activity with non-sterilized male partners, agreement to use two effective methods of contraception from the time of informed consent until the end of the study.
Who cannot join
- Presence of gastric or duodenal ulcer with current or recent bleeding as evidenced by endoscopy.
- Confirmed gastric cancer by endoscopic biopsy.
- Receipt of any investigational drug (including marketed drugs used in post-marketing studies) within 30 days prior to the screening period. Participants who failed screening and did not receive the investigational drug may be included.
- Participants who are investigators, relatives of investigators, or otherwise have conflicts of interest or may be under pressure to participate.
- History of cutaneous or systemic lupus erythematosus.
- Clinical manifestations of upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
Show all 20Show fewer
- Diagnosis of Zollinger-Ellison syndrome or other gastric acid hypersecretory disorders.
- Known allergy or hypersensitivity to Keverprazan Hydrochloride (including excipients), PPIs, amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, furazolidone, or excipients in 13C-UBT (mannitol, citric acid, or aspartame).
- History of alcohol abuse, illicit drug use, or drug addiction within 12 months prior to screening, or weekly alcohol intake exceeding 21 units (1 unit = 12 oz/300 ml beer, 1.5 oz/25 ml spirits, or 5 oz/100 ml wine).
- Use of antibiotics, bismuth agents, or antiprotozoal drugs within 30 days prior to 13C-UBT, or use of H2 receptor antagonists, PPIs, or interfering drugs (e.g., sodium succinate) within 14 days.
- Concurrent use of drugs contraindicated with clarithromycin (e.g., colchicine, pimozide, ergot derivatives, tadalafil, terfenadine, astemizole, cisapride, simvastatin, lovastatin, atorvastatin, etc.)..Use of pravastatin, fluvastatin, or rosuvastatin is permitted but should be used with caution.
- Concurrent use of strong CYP2C19 or CYP3A4 inhibitors or inducers (e.g., fluconazole, fluoxetine, fluvoxamine, ticlopidine, rifampin, ritonavir, itraconazole, ketoconazole, indinavir, nelfinavir, saquinavir, telithromycin).
- History of surgeries affecting gastric acid secretion, such as gastric resection or vagotomy.
- Significant central nervous, cardiovascular, hepatic, pulmonary, renal, metabolic, gastrointestinal, urological, reproductive, endocrine, or hematological disorders that may affect the study results or participant safety, as judged by the investigator.
- History of any malignancy, including MALT lymphoma.
- Need for hospitalization or surgery during the study or within 30 days prior to screening.
- Diagnosis of AIDS or HIV infection.
- Female participants who are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study or within 4 weeks after the study.
- Participants with negative H. pylori culture during the screening period.
- Participants with prior P-CAB plus amoxicillin dual therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiang Peng contact
About this study
Official title: A Multicenter, Randomized Controlled Study Comparing Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy in Helicobacter Pylori Rescue Treatment
This study aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. pylori is a common infectious disease associated with peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. However, the increasing resistance of H. pylori to antibiotics has reduced the eradication rates of standard therapies.
Potassium-competitive acid blockers (P-CABs), such as Keverprazan Hydrochloride, provide faster and more sustained gastric acid suppression compared to traditional proton pump inhibitors (PPIs), making them a promising option for H. pylori treatment. This multicenter, randomized controlled trial will provide critical evidence comparing the effectiveness of Keverprazan-based dual therapy to susceptibility-guided quadruple therapy, aiming to establish optimized rescue therapy guidelines for H. pylori eradication.
Read the detailed description
Helicobacter pylori (H. pylori) is a globally prevalent chronic infectious disease with an infection rate exceeding 50%. As a Gram-negative bacterium, H. pylori survives in the acidic gastric environment and is a major cause of peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Eradication of H. pylori can prevent the recurrence of peptic ulcers and reduce the risk of developing gastric cancer. However, increasing antibiotic resistance has significantly decreased the eradication rate of standard triple therapy to below 80%, posing a substantial challenge to effective H. pylori management.
This study focuses on evaluating a novel potassium-competitive acid blocker (P-CAB), Keverprazan Hydrochloride, in combination with Amoxicillin as dual therapy for H. pylori rescue treatment. P-CABs, including Keverprazan, offer rapid and sustained gastric acid suppression independent of CYP2C19 polymorphism, overcoming limitations of traditional proton pump inhibitors (PPIs). Recent studies have demonstrated the efficacy of P-CABs in first-line H. pylori treatment with high eradication rates and fewer side effects. However, evidence for their use in rescue therapy is currently lacking.
This multicenter, randomized controlled trial aims to compare the efficacy and safety of Keverprazan Hydrochloride-Amoxicillin dual therapy with susceptibility-guided quadruple therapy in patients requiring rescue treatment. The trial will involve patients with confirmed H. pylori infection who failed previous treatment regimens. The study's primary outcome is the eradication rate, and secondary outcomes include the incidence of adverse events and patient compliance.
This research is expected to provide critical evidence for the clinical application of Keverprazan Hydrochloride in H. pylori rescue therapy, potentially establishing it as an effective and patient-friendly treatment option.
- Being tested
- Keverprazan Hydrochloride tablets + high dose amoxicillin, Susceptibility-Guided Quadruple Therapy
- Keywords
- Helicobacter pylori, Keverprazan Hydrochloride, Susceptibility-guided therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keverprazan Hydrochloride tablets + high dose amoxicillinDrug
Keverprazan Hydrochloride, a potassium-competitive acid blocker (P-CAB), is administered at a dose of 20 mg twice daily in combination with Amoxicillin 0.75 g four times daily for 14 days. This dual therapy is designed to provide rapid and sustained gastric acid suppression and evaluate its efficacy in eradicating Helicobacter pylori.
Susceptibility-Guided Quadruple TherapyDrug
Participants in this arm will receive quadruple therapy tailored to individual H. pylori resistance profiles, including a proton pump inhibitor (Esomeprazole 20 mg), Bismuth Potassium Citrate 220 mg, and two antibiotics selected based on susceptibility testing (e.g., Amoxicillin, Clarithromycin, Metronidazole, Levofloxacin, or Furazolidone). The regimen is administered for 14 days to optimize eradication outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Keverprazan Hydrochloride + Amoxicillin | Experimental | Participants in this arm will receive Keverprazan Hydrochloride 20 mg twice daily and Amoxicillin 0.75 g four times daily for 14 days. This dual therapy aims to evaluate the efficacy of Keverprazan Hydrochloride, a potassium-competitive acid blocker, in combination with Amoxicillin for Helicobacter pylori eradication. Receives: Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin |
| Susceptibility-Guided Quadruple Therapy | Active comparator | Participants will receive susceptibility-guided quadruple therapy based on H. pylori resistance testing:
Clarithromycin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Clarithromycin 500 mg, twice daily for 14 days.
Metronidazole-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Metronidazole 400 mg, twice daily for 14 days.
Levofloxacin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g (twice daily), and Levofloxacin 500 mg (once daily) for 14 days.
Multi-drug resistant strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and either Furazolidone 0.1 g (twice daily) or Tetracycline 500 mg (four times daily) for 14 days.
For Amoxicillin-resistant strains, antibiotics will be adjusted based on susceptibility testing. Receives: Drug: Susceptibility-Guided Quadruple Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Successful Eradication of Helicobacter pylori
The proportion of participants who achieve successful eradication of Helicobacter pylori. Eradication is defined as a negative result on the 13C-Urea Breath Test (13C-UBT) conducted at least 4 weeks after the last dose of the study medication. The eradication rate will be calculated as: Eradication Rate=（Number of Participants with Successful Eradication/ Total number of participants）*100% This outcome will compare the efficacy of Keverprazan Hydrochloride + Amoxicillin dual therapy to susceptibility-guided quadruple therapy in the rescue treatment of H. pylori infection.
Measured: At least 4 weeks after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two groups: (1) Keverprazan Hydrochloride combined with Amoxicillin as a dual therapy, or (2) a susceptibility-guided quadruple therapy. Each group will receive the assigned treatment independently, and outcomes will be compared to assess the efficacy and safety of both regimens. Randomization ensures balanced allocation, and the parallel model allows for direct comparison of the two interventions under controlled conditions.
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Longgang District People's Hospital of Shenzhen, Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen Baoan District People's Hospital, Foshan Fuxing Chancheng Central Hospital
- Responsible party
- Principal investigator, Xiang Peng, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760065
- Sponsor's protocol ID
- KHDT-SGT
- Other IDs
- 1010-Program
- Acronym
- KHDT-SGT
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Study Comparing Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy in Helicobacter Pylori Rescue Treatment
- ClinicalTrials.gov ID
- NCT06760065
- Acronym / sponsor ID
- KHDT-SGT / KHDT-SGT
- Keywords
- Helicobacter pylori, Keverprazan Hydrochloride, Susceptibility-guided therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Longgang District People's Hospital of Shenzhen, Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen Baoan District People's Hospital, Foshan Fuxing Chancheng Central Hospital
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2025 (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 aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. pylori is a common infectious disease associated with peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. However, the increasing resistance of H. pylori to antibiotics has reduced the eradication rates of standard therapies.
Potassium-competitive acid blockers (P-CABs), such as Keverprazan Hydrochloride, provide faster and more sustained gastric acid suppression compared to traditional proton pump inhibitors (PPIs), making them a promising option for H. pylori treatment. This multicenter, randomized controlled trial will provide critical evidence comparing the effectiveness of Keverprazan-based dual therapy to susceptibility-guided quadruple therapy, aiming to establish optimized rescue therapy guidelines for H. pylori eradication.
Detailed description
Helicobacter pylori (H. pylori) is a globally prevalent chronic infectious disease with an infection rate exceeding 50%. As a Gram-negative bacterium, H. pylori survives in the acidic gastric environment and is a major cause of peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Eradication of H. pylori can prevent the recurrence of peptic ulcers and reduce the risk of developing gastric cancer. However, increasing antibiotic resistance has significantly decreased the eradication rate of standard triple therapy to below 80%, posing a substantial challenge to effective H. pylori management.
This study focuses on evaluating a novel potassium-competitive acid blocker (P-CAB), Keverprazan Hydrochloride, in combination with Amoxicillin as dual therapy for H. pylori rescue treatment. P-CABs, including Keverprazan, offer rapid and sustained gastric acid suppression independent of CYP2C19 polymorphism, overcoming limitations of traditional proton pump inhibitors (PPIs). Recent studies have demonstrated the efficacy of P-CABs in first-line H. pylori treatment with high eradication rates and fewer side effects. However, evidence for their use in rescue therapy is currently lacking.
This multicenter, randomized controlled trial aims to compare the efficacy and safety of Keverprazan Hydrochloride-Amoxicillin dual therapy with susceptibility-guided quadruple therapy in patients requiring rescue treatment. The trial will involve patients with confirmed H. pylori infection who failed previous treatment regimens. The study's primary outcome is the eradication rate, and secondary outcomes include the incidence of adverse events and patient compliance.
This research is expected to provide critical evidence for the clinical application of Keverprazan Hydrochloride in H. pylori rescue therapy, potentially establishing it as an effective and patient-friendly treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two groups: (1) Keverprazan Hydrochloride combined with Amoxicillin as a dual therapy, or (2) a susceptibility-guided quadruple therapy. Each group will receive the assigned treatment independently, and outcomes will be compared to assess the efficacy and safety of both regimens. Randomization ensures balanced allocation, and the parallel model allows for direct comparison of the two interventions under controlled conditions.
| Arm | Type | Receives |
|---|---|---|
| Keverprazan Hydrochloride + Amoxicillin | Experimental | Drug: Keverprazan Hydrochloride tablets + high dose amoxicillinParticipants in this arm will receive Keverprazan Hydrochloride 20 mg twice daily and Amoxicillin 0.75 g four times daily for 14 days. This dual therapy aims to evaluate the efficacy of Keverprazan Hydrochloride, a potassium-competitive acid blocker, in combination with Amoxicillin for Helicobacter pylori eradication. |
| Susceptibility-Guided Quadruple Therapy | Active comparator | Drug: Susceptibility-Guided Quadruple TherapyParticipants will receive susceptibility-guided quadruple therapy based on H. pylori resistance testing: Clarithromycin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Clarithromycin 500 mg, twice daily for 14 days. Metronidazole-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and Metronidazole 400 mg, twice daily for 14 days. Levofloxacin-sensitive strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g (twice daily), and Levofloxacin 500 mg (once daily) for 14 days. Multi-drug resistant strains: Esomeprazole 20 mg, Bismuth Potassium Citrate 220 mg, Amoxicillin 1 g, and either Furazolidone 0.1 g (twice daily) or Tetracycline 500 mg (four times daily) for 14 days. For Amoxicillin-resistant strains, antibiotics will be adjusted based on susceptibility testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged ≥18 years and ≤75 years at the time of signing the informed consent.
- Participants who have undergone at least one prior standard H. pylori eradication treatment but failed.
- Current H. pylori infection confirmed by 13C-UBT, or H. pylori culture.
- Participants who, in the investigator's opinion, are able to understand and comply with the study requirements.
- Written informed consent and any required privacy authorization documents signed and dated before the initiation of any study procedures.
Key exclusion criteria (20 listed)
- Presence of gastric or duodenal ulcer with current or recent bleeding as evidenced by endoscopy.
- Confirmed gastric cancer by endoscopic biopsy.
- Receipt of any investigational drug (including marketed drugs used in post-marketing studies) within 30 days prior to the screening period. Participants who failed screening and did not receive the investigational drug may be included.
- Participants who are investigators, relatives of investigators, or otherwise have conflicts of interest or may be under pressure to participate.
- History of cutaneous or systemic lupus erythematosus.
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 |
|---|---|---|
| Keverprazan Hydrochloride tablets + high dose amoxicillinKeverprazan Hydrochloride, a potassium-competitive acid blocker (P-CAB), is administered at a dose of 20 mg twice daily in combination with Amoxicillin 0.75 g four times daily for 14 days. This dual therapy is designed to provide rapid and sustained gastric acid suppression and evaluate its efficacy in eradicating Helicobacter pylori. | Drug | Keverprazan Hydrochloride + Amoxicillin |
| Susceptibility-Guided Quadruple TherapyParticipants in this arm will receive quadruple therapy tailored to individual H. pylori resistance profiles, including a proton pump inhibitor (Esomeprazole 20 mg), Bismuth Potassium Citrate 220 mg, and two antibiotics selected based on susceptibility testing (e.g., Amoxicillin, Clarithromycin, Metronidazole, Levofloxacin, or Furazolidone). The regimen is administered for 14 days to optimize eradication outcomes. | Drug | Susceptibility-Guided Quadruple Therapy |
Primary outcome
Proportion of Participants with Successful Eradication of Helicobacter pylori
Time frame: At least 4 weeks after the last dose of study medication
The proportion of participants who achieve successful eradication of Helicobacter pylori. Eradication is defined as a negative result on the 13C-Urea Breath Test (13C-UBT) conducted at least 4 weeks after the last dose of the study medication. The eradication rate will be calculated as: Eradication Rate=（Number of Participants with Successful Eradication/ Total number of participants）*100% This outcome will compare the efficacy of Keverprazan Hydrochloride + Amoxicillin dual therapy to susceptibility-guided quadruple therapy in the rescue treatment of H. pylori infection.
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 9 Jan 2025.
- Individual participant dataSharing planned: No
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.
Xiang Peng contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Keverprazan Hydrochloride tablets + high dose amoxicillin and Susceptibility-Guided Quadruple Therapy in people with Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Contact Xiang Peng (+86-020-3825401), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Successful Eradication of Helicobacter pylori (time frame: At least 4 weeks after the last dose of study medication). 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 9 Jan 2025.