Trial · NCT02584777
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants achieving a ≥35% reduction in spleen volume | Baseline to Week 24 | Measured by MRI or CT scan |
| Secondary | Proportion of participants with ≥50% reduction in total symptom score (TSS) | Baseline to Week 24 | Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) TSS 2.0 |
| Secondary | Proportion of participants with baseline platelet count <100,000/μL achieving ≥35% reduction in spleen volume | Baseline to Week 24 | Measured by MRI or CT scan |
| Secondary | Proportion of participants with baseline platelet count <100,000/μL achieving ≥50% reduction in total symptom score (TSS) | Baseline to Week 24 | |
| Secondary | Proportion of participants with baseline platelet count <50,000/μL achieving ≥35% reduction in spleen volume | Baseline to Week 24 | Measured by MRI or CT scan |
| Secondary | Proportion of participants with baseline platelet count <50,000/μL achieving ≥50% reduction in total symptom score (TSS) | Baseline to Week 24 | |
| Secondary | Clinically significant adverse events (AEs) | Throughout the study period of approximately 5 years | |
| Secondary | Clinically significant changes in laboratory results | Throughout the study period of approximately 5 years | |
| Secondary | Clinically significant changes in vital signs | Throughout the study period of approximately 5 years | |
| Secondary | Clinically significant changes in electrocardiograms (ECGs) | Throughout the study period of approximately 5 years | |
| Secondary | Pacritinib pharmacokinetic (PK) parameter: maximum observed concentration (Cmax) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pacritinib pharmacokinetic (PK) parameter: Time of maximum observed concentration (Tmax) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pacritinib pharmacokinetic (PK) parameter: minimum observed concentration (Cmin) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pacritinib pharmacokinetic (PK) parameter: area under the concentration curve (AUC) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pacritinib pharmacokinetic (PK) parameter: apparent volume of distribution (V/F) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pharmacodynamic parameter: Maximum observed effect (Emax) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pharmacodynamic parameter: time of maximum observed effect (tEmax) | Baseline; weeks 3, 12 & 24 | |
| Secondary | Pharmacodynamic parameter: area under the effect curve (AUEC) | Baseline; weeks 3, 12 & 24 |
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/NCT02584777/registered