Trial · NCT04687072
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Chronic Immune Thrombocytopenia (ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24 | Up to 6 weeks (between Weeks 19 and 24) | Full Analysis Set (FAS)-Chronic: Participants from the FAS (all randomized participants) including only participants with chronic ITP. | percentage of participants | NUMBER |
| SECONDARY | Extent of Disease Control Over the 24-Week Treatment Period in the Chronic ITP Population | Up to 24 weeks | FAS-Chronic: Participants from the FAS (all randomized participants) including only participants with chronic ITP. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants in the Overall Population (Chronic and Persistent ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24 | Up to 6 weeks (between Weeks 19 and 24) | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in the Overall Population With Sustained Platelet Count Response Between Weeks 17 and 24 | Up to 8 weeks (between Weeks 17 and 24) | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in the Overall Population Achieving Overall Platelet Count Response at Any Time During the 24-week Treatment Period | Up to 24 weeks | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Extent of Disease Control Until Week 12 in the Overall Population | Up to 12 weeks | FAS: All randomized participants. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants in the Overall Population Achieving Overall Platelet Count Response at Any Time Until Week 12 | Up to 12 weeks | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Platelet Count at Each Visit in the Overall Population | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Safety and Efficacy Follow-up Visit 1 (SEFU1) (up to Week 29), and SEFU2 (up to Week 33) | FAS: All randomized participants with available data. | platelets x10^9/L | MEAN |
| SECONDARY | Time to Platelet Count Response in the Overall Population | Up to 24 weeks | FAS: All randomized participants. Participants with no occurrence of platelet count response, early discontinuation of treatment, or dose and/or frequency of concurrent ITP therapy increased or a new ITP therapy were censored. If multiple censoring conditions apply, the earliest censoring date is considered. | days | MEDIAN |
| SECONDARY | Extent of Disease Control Over the 24-Week Treatment Period in the Overall Population | Up to 24 weeks | FAS: All randomized participants. | weeks | MEDIAN |
| SECONDARY | Extent of Disease Control Over the 24-Week Treatment Period in the Overall Population for Participants With Baseline Platelet Count of <15×10^9/L | Up to 24 weeks | FAS: All randomized participants with Baseline Platelet Count of \<15×10\^9/L. | weeks | MEDIAN |
| SECONDARY | Number of the World Health Organization (WHO)-Classified Bleeding Events (Grade ≥1) in the Overall Population | Up to 24 weeks | FAS: All randomized participants. | bleeding events | MEDIAN |
| SECONDARY | Percentage of Participants With a Platelet Count International Working Group (IWG) Response | Up to 24 weeks | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Rate of Receipt of Rescue Therapy (Rescue Per Participant Per Month) in the Overall Population | Up to 24 weeks | FAS: All randomized participants. | rescues per participant per month | MEAN |
| SECONDARY | Percentage of Participants for Whom Dose and/or Frequency of Concurrent ITP Therapies Have Increased at Week 12 or Later in the Overall Population | Up to 13 weeks (between Weeks 12 and 24) | FAS: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 24 in the Overall Population | Baseline and Week 24 | FAS: All randomized participants. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy Questionnaire-Th6 (Fact-Th6) at Week 24 in the Overall Population | Baseline and Weeks 4, 8, 12, 16, 20, and 24 | FAS: All randomized participants. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) at Week 24 in the Overall Population | Baseline and Week 24 | FAS: All randomized participants. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence and Prevalence of Antibodies to Efgartigimod and/or rHuPH20 in the Overall Population | Up to 35 weeks | SAF: All participants who received at least 1 dose or part of a dose including only antibody-evaluable participants. | percentage of participants | NUMBER |
| SECONDARY | Titers of Antibodies to Efgartigimod and/or rHuPH20 in the Overall Population | Weeks 3, 7, 11, 15, 19, 23, 24, SEFU1 (up to Week 29), and SEFU2 (up to Week 33) | SAF: All participants who received at least 1 dose or part of a dose with available data. | titer | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04687072/outcomes