Trial · NCT06847867
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with Red Blood Cells - transfusion independence (RBC-TI) for at least 12 weeks, rolling over 24 weeks | Up to 24 weeks | RBC-TI defined as not requiring RBC transfusions (except in the case of clinically overt bleeding). Percentage of participants with RBC-TI will be measured for any consecutive 12-week interval over 24-week duration. |
| Primary | Number of participants with Grade 3 Adverse events (AEs), AE leading to treatment discontinuation and AEs leading to dose modifications | Up to approximately 109 weeks | |
| Primary | Maximum plasma concentration (Cmax) of momelotinib and major metabolite of momelotinib (M21) | Up to 24 weeks | |
| Primary | Area under the plasma concentration versus time curve (AUC) of momelotinib and M21 | Up to 24 weeks | |
| Secondary | Percentage of participants with ≥16 weeks of RBC-TI by the end of Week 24 | At week 24 | RBC-TI defined as not requiring RBC transfusions (except in the case of clinically overt bleeding). Percentage of participants with RBC-TI will be measured for any consecutive ≥16-week interval by the end of Week 24. |
| Secondary | Percentage of participants with ≥1.5 grams per deciliter (g/dL) increase in hemoglobin | Up to 24 weeks | |
| Secondary | Percentage of participants with ≥24 weeks of RBC-TI by the end of Week 48 | At week 48 | RBC-TI defined as not requiring RBC transfusions (except in the case of clinically overt bleeding). Percentage of participants with RBC-TI will be measured for any consecutive ≥24-week interval by the end of Week 48. |
| Secondary | Number of participants with hematologic improvement (HI-E) response per International Working Group (IWG) 2018 criteria | Up to 24 weeks | HI-E response is measured based on the combined incidence of: Low transfusion burden (LTB) patients: absence of any transfusion for ≥ 8 consecutive weeks. High transfusion burden (HTB) patients: minor response defined as reduction by ≥ 50% of red blood cell (RBC) units for ≥ 8 consecutive weeks. Major response defined as absence of RBC transfusions for ≥ 8 consecutive weeks or longer up to 24 weeks |
| Secondary | Time to RBC-TI by Weeks 24 and 48 | Up to Weeks 24 and 48 | Time to RBC-TI defined as the time from the first dose of study intervention until the first date of TI (absence of RBC transfusion requirement). |
| Secondary | Number of participants with AEs, Serious adverse events (SAEs), AEs leading to treatment discontinuation, and AEs leading to dose modifications | Up to approximately 133 weeks | |
| Secondary | Number of participants with AEs, SAEs, AEs leading to treatment discontinuation, and AEs leading to dose modifications by Severity | Up to approximately 133 weeks | |
| Secondary | Number of participants with clinically significant changes in laboratory parameters | Up to approximately 133 weeks | |
| Secondary | Number of participants with clinically significant changes in vital signs | Up to approximately 133 weeks | |
| Secondary | Plasma concentration of momelotinib and M21 | Up to 24 weeks |
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/NCT06847867/registered