Trial · NCT07506863
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Transfusion Reduction Response (TRR) Through Week 48 | Baseline, through Week 48 | TRR is defined as ≥50 percent (%) reduction in transfused red blood cells (RBC) volume (normalized by weight) in any consecutive 12-week period through Week 48 compared with historical RBC transfusion volume (normalized by weight) and standardized to 12 weeks. |
| Secondary | Percentage of Participants Who Achieved TRR2 From Week 13 to Week 24 | Baseline, Week 13 through Week 24 | TRR2 is defined as ≥50% reduction in transfused RBC volume (normalized by weight) from week 13 to week 24 compared with historical RBC transfusion volume (normalized by weight) and standardized to 12 weeks. |
| Secondary | Percentage of Participants Who Achieved TRR3 From Week 25 to Week 36 | Baseline, Week 25 through Week 36 | TRR3 is defined as ≥50% reduction in transfused RBC volume (normalized by weight) from week 25 to week 36 compared with historical RBC transfusion volume (Normalized by Weight) and standardized to 12 weeks. |
| Secondary | Percentage of Participants Who Achieved TRR4 From Week 37 to Week 48 | Baseline, Week 37 through Week 48 | TRR4 is defined as ≥50% reduction in transfused RBC volume (normalized by weight) from week 37 to week 48 compared with historical RBC transfusion volume (normalized by weight) and standardized to 12 weeks. |
| Secondary | Percentage of Participants Who Achieved TRR5 From Week 25 to Week 48 | Baseline, Week 25 through Week 48 | TRR5 is defined as ≥50% reduction in transfused RBC volume (normalized by weight) from week 25 to week 48 compared with historical RBC transfusion volume (normalized by weight) and standardized to 24 weeks. |
| Secondary | Percent Change in Transfused RBC Volume (Normalized by Weight) From Week 13 Through Week 48 Compared With Historical Transfusion Volume (Normalized by Weight) and Standardized to 36 Weeks | Baseline, Week 13 through Week 48 | |
| Secondary | Percentage of Participants Who Achieved Transfused Independence Through Week 48 | Baseline, through Week 48 | Transfusion independence is defined as transfusion-free for greater than or equal to 8 consecutive weeks through Week 48. |
| Secondary | Change in the Number of Transfusion Episodes From Week 13 Through Week 48 Compared With Historical Number of Transfusion Episodes Standardized to 36 Weeks | Baseline, Week 13 through Week 48 | |
| Secondary | Change From Baseline in Serum Iron at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline in Total Iron-Binding Capacity at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline in Transferrin at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline in Transferrin Saturation at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline in Serum Ferritin Levels at Week 48 | Baseline, Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Estradiol Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Estrone Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Total Testosterone Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Free Testosterone Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Luteinizing Hormone Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Change From Baseline in Sexual Maturity Rating With Tanner Stage Through Week 48 | Baseline, through Week 48 | |
| Secondary | Cohort 1: Percentage of Female Participants With Newly Developed Ovarian Cysts Through Week 48 | Baseline, through Week 48 |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07506863/registered