Trial · NCT07414394
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 24 | At Week 24 | Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 24 after randomized treatment with Tigulixostat (IBI128) or Febuxostat in Chinese participants with gout. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 12 | At Week 12 | Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 12. |
| Secondary | Proportion of Participants with Serum Uric Acid <360 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Proportion of participants achieving a serum uric acid (sUA) level \<360 μmol/L at each scheduled visit during the 52-week study period. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <300 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Percentage of participants with serum uric acid (sUA) level below 300 μmol/L at each scheduled visit during the 52-week treatment period. |
| Secondary | Proportion of Participants Achieving Serum Uric Acid <240 μmol/L at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Percentage of participants with serum uric acid (sUA) level below 240 μmol/L at each scheduled visit during the 52-week treatment period. |
| Secondary | Mean Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Mean change from baseline in serum uric acid (sUA) level at each scheduled visit during the 52-week treatment period. |
| Secondary | Mean Percent Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit | At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52 | Mean percent change from baseline in serum uric acid (sUA) level at each scheduled visit the 52-week treatment period. |
| Secondary | Number of Participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) | Baseline through Week 54 (end of safety follow-up) | Percentage of participants who have experienced AEs/SAEs. |
| Secondary | Proportion and Number of Gout Flares per Participant | Every 4 weeks from first dose through Week 52 | Proportion of participants experiencing gout flares and the number of gout flares per participant during each 4-week interval following initiation of study treatment. |
| Secondary | Change From Baseline in Renal Function Parameters | At Week 12, 24, and 52 | Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 12, 24, and 52. |
| Secondary | Change From Baseline in Renal Function Parameters | At Weeks 12, 24, and 52 | Change from baseline in urine albumin-to-creatinine ratio (UACR) at Weeks 12, 24, and 52. |
| Secondary | Change From Baseline in Inflammatory and Deposition-Related Parameters | At Weeks 12, 24, and 52 | Change from baseline in urolithiasis status, gouty tophi, and systemic inflammation as assessed by high-sensitivity C-reactive protein (hs-CRP) at Weeks 12, 24, and 52. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07414394/registered