Trial · NCT07332091
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) | At Baseline and Day 360 | |
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs) | Up to Day 390 | |
| Secondary | Percentage of participants with TEAEs | Up to Day 390 | |
| Secondary | Number of participants with treatment-emergent serious adverse events (SAEs) | Up to Day 390 | |
| Secondary | Percentage of participants with treatment-emergent SAEs | Up to Day 390 | |
| Secondary | Number of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead electrocardiogram (ECG) | From Baseline to Day 390 | Clinical safety laboratory tests will include hematology, biochemistry and coagulation. |
| Secondary | Percentage of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead ECG | From Baseline to Day 390 | Clinical safety laboratory tests will include hematology, biochemistry and coagulation. |
| Secondary | Change from baseline in transferrin saturation (TSAT) (measured at trough) | From Baseline to Day 360 | |
| Secondary | Number of participants with TSAT less than or equal to (<=) 45% (measured at trough) | From Baseline to Day 360 | |
| Secondary | Percentage of participants with TSAT <= 45% (measured at trough) | From Baseline to Day 360 | |
| Secondary | Number of participants with 25% reduction in MRI-based LIC | At Day 180 and 360 | |
| Secondary | Number of participants with 50% reduction in MRI-based LIC | At Day 180 and Day 360 | |
| Secondary | Number of participants with TSAT ≤ 45% or MRI-based LIC < 5 milligrams per gram (mg/g) | At Day 360 | |
| Secondary | Number of participants with TSAT ≤ 45% or MRI-based LIC < 2 mg/g | At Day 360 | |
| Secondary | Change from baseline in joint pain score in a visual analog scale (VAS) | From Baseline to Day 360 | The VAS is a single-item questionnaire. Participants will be asked to record their joint pain at its worst over the previous week, from 0 (No pain) to 10 (Worst possible pain). |
| Secondary | Change from baseline in modified fatigue impact scale (MFIS) total score | From Baseline to Day 360 | Participants will be asked to read a list of 21 statements and assess how often fatigue has affected them in terms of physical, cognitive, and psychosocial functioning, over the previous 4 weeks, using a 5-point scale from 0 (Never) to 4 (Almost always). The total score is obtained by summing the scores of all the 21 items. Higher scores indicate a greater impact of fatigue on a participant's activities. |
| Secondary | Change from baseline in health-related quality of life: EuroQoL 5-dimension 5-level instrument (EQ-5D-5L) | From Baseline to Days 180, 360, and 390 | The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health for clinical and economic appraisal. Participants will complete the questionnaire based on their health on that day. The EQ-5D-5L descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Participants will rate each dimension based on 5 levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. A higher score indicates a more severe outcome than a lower score. |
| Secondary | Change from baseline in health-related quality of life: VAS (Arthralgia) | From Baseline to Day 180, 360, and 390 | The VAS is a single-item questionnaire. Participants will be asked to record their joint pain at its worst over the previous week, from 0 (No pain) to 10 (Worst possible pain). |
| Secondary | Change from baseline in health-related quality of life: Patient global impression of change in clinical status | From Baseline to Day 180, 360, and 390 | The PGI - Change (PGI-C) instrument is a self-reported measure that reflects belief about the efficacy of treatment. Participants will be asked to rate the change in their overall symptoms since they started taking investigational product (IP) on a 5-point scale, ranging from 1 (Much improved) to 5 (Much worse). A lower score reflects an improvement in clinical status. |
| Secondary | Change from baseline in health-related quality of life: Patient global impression of severity | From Baseline to Day 180, 360, and 390 | The PGI - Severity (PGI-S) instrument is a self-reported questionnaire and consists of 1 item that measures disease severity. Participants will be asked to rate the severity of their overall symptoms over the previous week on a 5-point scale from 1 (None) to 5 (Very severe). A higher score reflects a more severe outcome than a lower score. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
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