Trial · NCT02515630
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transfusion Independence Response by Week 24 | From baseline to Week 24 | The percentage of subjects who became transfusion independent for ≥ 12 weeks at any time on study. A subject was considered transfusion independent on study if no RBC transfusion occurred in any 12-week period during the 24-week treatment period. |
| Secondary | Transfusion Response Rate by Week 24 | From baseline to Week 24 | The percentage of subjects who became transfusion independent for ≥ 8 weeks, defined as no RBC transfusions for at least an 8-week period at any time on study. |
| Secondary | Splenic Response Rate at Week 24 | Measured at Week 24 | The percentage of subjects who achieved a ≥ 35% reduction in spleen volume from baseline as measured by MRI at Week 24. |
| Secondary | Response Rate in Total Symptom Score (TSS) at Week 24 | Measured at Week 24 | The percentage of subjects achieving a ≥ 50% reduction from baseline in TSS at Week 24, as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) diary. Total symptom score was assessed using the modified MPN-SAF TSS Version 2, an 8-item questionnaire developed to assess symptom burden and quality of life in patients with MPN. The modified MPN-SAF TSS contained 8 questions, 7 of which were summed to generate the score (the included questions related to tiredness, early satiety, abdominal discomfort, night sweats, itching, bone pain, and pain under the ribs on the left side). Each question is scored on a scale of 0-10, where higher numbers indicate more severe symptoms. For this study, the TSS scale ranges from 0 to 70. The questionnaire was completed daily on an electronic diary device. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | Hepcidin daily change (in nM) was calculated as the predose value subtracted from the 6 hours postdose value at each study visit. Daily hepcidin change at the baseline visit was the difference between 2 values obtained 6 hours apart. No momelotinib was administered on that day. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin | At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24 | Median hepcidin at trough was assessed predose at each study visit. |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Serum Iron | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in serum iron, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Hemoglobin | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in hemoglobin, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in total iron binding capacity, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Reticulocytes | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in reticulocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes% | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in reticulocytes/erythrocytes%, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Erythropoietin | At Weeks 8 and 20 | Percent change in erythropoietin at Weeks 8 and 20. The baseline erythropoietin value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Erythrocytes | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in erythrocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Hematocrit | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in hematocrit, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Ferritin | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in ferritin, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in soluble transferrin receptor, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in transferrin saturation, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in unsaturated iron binding capacity, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Platelets | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in platelets, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
| Secondary | Change in Markers of Iron Metabolism and Anemia - Leukocytes | At Weeks 2, 4, 8, 12, 16, 20 and 24 | Percent change from baseline in leukocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit). |
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
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GET https://conductscience.org/api/trials/v1/NCT02515630/registered