Trial · NCT06198712
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Single-dose: maximum plasma concentration (Cmax) | During the 24-week primary treatment period | |
| Primary | Single-dose: area under the plasma concentration time curve from dosing (time 0) to time t ((AUC)0-t) | During the 24-week primary treatment period | |
| Primary | Single-dose: area under the plasma concentration time curve from zero to time infinity (AUC0-inf) | During the 24-week primary treatment period | |
| Primary | Steady-state maximum plasma concentration (Cmax,ss) | During the 24-week primary treatment period | |
| Primary | Steady-state area under the concentration time curve over the dosing interval (AUCtau,ss) | During the 24-week primary treatment period | |
| Primary | Steady-state average plasma concentration (Cavg,ss) | During the 24-week primary treatment period | |
| Primary | Steady-state minimum plasma concentration (Cmin,ss) | During the 24-week primary treatment period | |
| Primary | Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs related to etavopivat | During the 24-week primary treatment period | |
| Primary | Number of premature discontinuations | During the 24-week primary treatment period | |
| Primary | Number of dose interruptions | During the 24-week primary treatment period | |
| Primary | Number of dose reductions | During the 24-week primary treatment period | |
| Secondary | Incidence of AEs, SAEs, and AEs related to etavopivat | During the 72-week treatment extension period | |
| Secondary | Number of premature discontinuations | During the 72-week treatment extension period | |
| Secondary | Number of dose interruptions | During the 72-week treatment extension period | |
| Secondary | Number of dose reductions | During the 72-week treatment extension period | |
| Secondary | Hemoglobin (Hb) response rate | Baseline, week 12 and 24 | |
| Secondary | Change in Hb from baseline | Baseline, week 12 and 24 | |
| Secondary | Change from baseline in number of vaso-occlusive crises (VOCs) | Baseline and week 24 | |
| Secondary | Change from baseline in Annualized Rate of VOC | Baseline and week 24 | |
| Secondary | Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale | Baseline, week 12 and 24 | PROMIS is a 10-item patient-reported health outcome measurement system used to evaluate quality of life in both children and adults. The assessment is based on the responses - 1. Never, 2. Almost never, 3. Sometimes, 4. Often and 5. Almost always. 'Never' response on the PROMIS fatigue scale indicates better quality of life. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06198712/registered