Trial · NCT05175105
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Hemoglobin (Hb) Response | Baseline up to Week 20 | Hb response is defined as a ≥1.5 grams per deciliter (g/dL) (0.93 millimoles per liter \[mmol/L\]) increase in Hb concentration from baseline that is sustained at 2 or more scheduled assessments at Weeks 12, 16, and 20 during the double-blind period. The individual participant's baseline Hb concentration is defined as the average of all available Hb concentrations collected for that participant during the screening period up to the first dose of study drug. |
| Secondary | Average Change From Baseline in Hb Concentration at Weeks 12, 16, and 20 | Baseline, Weeks 12, 16, and 20 | |
| Secondary | Maximal Change in Hb Concentration From Baseline During the Double-blind Period | Baseline up to Week 20 | |
| Secondary | Change From Baseline in Estradiol Concentration | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Estrone Concentration | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Total Testosterone Concentration | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Free Testosterone Concentration in Participants ≥7 Years of Age or Tanner Stage ≥2 (Whichever Occurs First) | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Luteinizing Hormone Concentration in Participants ≥6 Years of Age | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Sexual Maturity Rating with Tanner Stage | Baseline up to Week 286 | Tanner Stage 1 corresponds to the prepubertal form, with progression to Tanner Stage 5, the final adult form. |
| Secondary | Number of Female Participants With Development of Ovarian Cysts | Baseline up to Week 286 | |
| Secondary | Change From Baseline in the Size of Ovarian Cysts in Female Participants | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Height-for-age Z-score | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Weight-for-age Z-score | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Body Mass Index (BMI)-for-age Z-score | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Bone Mineral Density (BMD) Z-score | Baseline up to Week 286 | |
| Secondary | Average Change From Baseline in Indirect Bilirubin Concentration at Weeks 12, 16, and 20 | Baseline, Weeks 12, 16, and 20 | |
| Secondary | Average Change From Baseline in Lactose Dehydrogenase (LDH) Concentration at Weeks 12, 16, and 20 | Baseline, Weeks 12, 16, and 20 | |
| Secondary | Change From Baseline in Haptoglobin Concentration at Week 16 | Baseline, Week 16 | |
| Secondary | Change From Baseline in Reticulocytes | Baseline up to Week 286 | |
| Secondary | Change From Baseline in Serum Iron Concentration | Baseline up to Week 280 |
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/NCT05175105/registered