Trial · NCT04480086
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Up To Approximately 1 year from start of study | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Secondary | Percentage of Participants who Achieve Spleen Volume Reduction of 35% or Greater (SVR35) | Up To Week 24 | Reduction in spleen volume is measured by magnetic resonance imaging (MRI). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Mivebresib | Up To Week 12 | Maximum observed plasma concentration (Cmax) of Mivebresib. |
| Secondary | Time to Cmax (Tmax) of Mivebresib | Up To Week 12 | The amount of time taken to reach Cmax. |
| Secondary | Area Under Concentration vs Time Curve (AUC) of Mivebresib | Up To Week 12 | AUC of Mivebresib will be calculated. |
| Secondary | Half-Life (t1/2) of Mivebresib | Up To Week 12 | Half-life of Mivebresib will be calculated. |
| Secondary | Accumulation Ratio of Mivebresib | Up To Week 12 | Pharmacokinetic parameters will include accumulation ratio of Mivebresib. |
| Secondary | Apparent Clearance (CL/F) of Mivebresib | Up To Week 12 | CL/F of Mivebresib will be calculated. |
| Secondary | Apparent Volume of Distribution (Vd/F) of Mivebresib | Up To Week 12 | Vd/F of mivebresib will be calculated. |
| Secondary | Percentage of Participants With >= 50% Reduction in Total Symptom Score (TSS) | Week 24 | TSS is assessed using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. MFSAF v4.0 measures the burden of myelofibrosis-related symptoms. The symptoms are assessed on a 11-point numeric rating scale (NRS) anchored from 0 (absent) to 10 (worst imaginable). |
| Secondary | Objective Response Rate (ORR) | Week 24 | ORR is defined as the sum of rates of complete remission (CR) and partial remission (PR). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Navitoclax | Up To Week 12 | Maximum Observed Plasma Concentration (Cmax) Of Navitoclax. |
| Secondary | Time to Cmax (Tmax) of Navitoclax | Up To Week 12 | The amount of time taken to reach Cmax. |
| Secondary | Area Under Concentration vs Time Curve (AUC) of Navitoclax | Up To Week 12 | AUC of Navitoclax will be calculated. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib | Up To Week 12 | Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib. |
| Secondary | Time to Cmax (Tmax) of Ruxolitinib | Up To Week 12 | The amount of time taken to reach Cmax. |
| Secondary | Area Under Concentration vs Time Curve (AUC) of Ruxolitinib | Up To Week 12 | AUC of Ruxolitinib will be calculated. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
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GET https://conductscience.org/api/trials/v1/NCT04480086/registered