Trial · NCT02069899
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Event (AE) | From the date of enrollment in this study up to 1 year either after HSCT or after the last administration of emapalumab (maximum duration: 639 days) | Participants who previously received treatment in a parent study (NI-0501-04 or NI-0501-06) or under compassionate use and who provided informed consent for participation in Study NI-0501-05. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Duration of Response (Enrolled-04 Cohort) | From 1st achievement of overall response until HSCT or last treatment date if participant did not undergo HSCT (maximum 250 days) | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who had at least 1 response. | days | MEAN |
| SECONDARY | Duration of First Response (Enrolled-06 Cohort) | From first date of response and first date of loss of response or death (maximum 416 days) | Enrolled-06 population included participants previously enrolled and treated in Study NI-0501-06 (participants with MAS in Still's disease) who provided informed consent for participation in Study NI-0501-05 and who had at least 1 response. | days | MEDIAN |
| SECONDARY | Overall Survival (Enrolled-04 Cohort) | From the date of last of emapalumab dose to the date of death or last contact or 12 months after last dose, whichever came first (maximum 366 days) | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05. | days | MEDIAN |
| SECONDARY | Overall Survival (Enrolled-06 Cohort) | From the date of last of emapalumab dose to the date of death or last contact or 12 months after last dose, whichever came first (maximum 366 days) | Enrolled-06 population included participants previously enrolled and treated in Study NI-0501-06 (participants with MAS in Still's disease) who provided informed consent for participation in Study NI-0501-05. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved Engraftment (Enrolled-04 Cohort) | From HSCT up to 12 months | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who underwent HSCT. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Donor Chimerism (Enrolled-04 Cohort) | From HSCT to 12 months | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who underwent HSCT. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Graft-versus-host-disease (Enrolled-04 Cohort) | From HSCT to 12 months | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who underwent HSCT. | percentage of participants | NUMBER |
| SECONDARY | MAS Activity Level as Assessed by Visual Analogue Scale (Enrolled-06 Cohort) | Baseline (first NI-0501-05 visit), Day 100, Month 12/End of Study | Enrolled-06 population included participants previously enrolled and treated in Study NI-0501-06 (participants with MAS in Still's disease) who provided informed consent for participation in Study NI-0501-05 and had available data for MAS activity. | score on a scale | MEAN |
| SECONDARY | Circulating Emapalumab Level (Enrolled-04 Cohort) | First infusion day (infusion duration: 1-2 hours) in Study NI-0501-05, last infusion day (infusion Day 188), 12 months post-transplant | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who had data available for specified timepoints. Circulating emapalumab level post-transplant included participants who had HSCT and data available at 12 months post-HSCT (Samples were not to be taken once it had been determined that emapalumab was below measurable level of 62.5 µg/L). | µg/L | MEAN |
| SECONDARY | Circulating Emapalumab Level (Enrolled-06 Cohort) | Baseline (first NI-0501-05 visit), Day 100, Month 6 | Enrolled-06 population included participants previously enrolled and treated in Study NI-0501-06 (participants with MAS in Still's disease) who provided informed consent for participation in Study NI-0501-05 and had available data at specified timepoints (Samples were not to be taken once it had been determined that emapalumab was below measurable level of 62.5 µg/L). | µg/L | MEAN |
| SECONDARY | Total Human Interferon Gamma Levels (Enrolled-04 Cohort) | First infusion day (infusion duration: 1-2 hours) in Study NI-0501-05, Day 100 post-transplant, 12 months post-transplant | Enrolled-04 population included participants previously enrolled and treated in Study NI-0501-04 (participants with primary HLH) who provided informed consent for participation in Study NI-0501-05 and who had data available for specified timepoints. Total human interferon gamma levels post-transplant included participants who underwent HSCT and data available at Day 100 and 12 months post-HSCT. | ng/L | MEAN |
| SECONDARY | Total Human Interferon Gamma Levels (Enrolled-06 Cohort) | Baseline (first NI-0501-05 visit), Day 100, Month 12/End of Study | Enrolled-06 population included participants previously enrolled and treated in Study NI-0501-06 (participants with MAS in Still's disease) who provided informed consent for participation in Study NI-0501-05 and had available data at specified timepoints. | ng/L | MEAN |
| SECONDARY | Number of Participants With Anti-drug Antibody | From enrolment up to 12 months post-transplant or last emapalumab infusion (maximum 639 days) | Participants who previously received treatment in a parent study (NI-0501-04 or NI-0501-06) or under CU and who provided informed consent for participation in Study NI-0501-05. Number of participants analysed included participants who had available data for anti-drug antibody. | Participants | COUNT_OF_PARTICIPANTS |
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.
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