Trial · NCT06544499
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extent of disease control, defined as the number of cumulative weeks during the 24-week Double-Blinded Treatment Period with platelet counts of at least 50 × 10^9/L | Up to 24 weeks | |
| Secondary | Proportion of participants achieving platelet counts of at least 50 × 10^9/L for at least 4 of the 6 study visits between study weeks 19 and 24 of the DBTP | Up to 6 weeks | |
| Secondary | Proportion of participants achieving platelet counts of at least 50 × 10^9/L for at least 6 of the 8 study visits between study weeks 17 and 24 of the DBTP | Up to 8 weeks | |
| Secondary | Proportion of participants achieving a platelet counts of at least 50 × 10^9/L for at least 8 of the 12 study visits between weeks 13 and 24 of the DBTP | Up to 12 weeks | |
| Secondary | Proportion of participants achieving a platelet count of at least 50 × 10^9/L on at least 4 occasions at any time until study week 12 during the DBTP | Up to 12 weeks | |
| Secondary | Time to response, defined as the time to achieve 2 consecutive platelet counts of at least 50 × 10^9/L at any time during the DBTP | up to 24 weeks | |
| Secondary | Proportion of participants with an IWG response during the DBTP | Up to 24 weeks | International Working Group (IWG) |
| Secondary | Proportion of participants with initial response, defined as a platelet count of at least 30 × 10^9/L and a 2-fold increase from baseline in platelet count at study week 5 of the DBTP | Up to 20 weeks | |
| Secondary | Time to achieve a platelet count of at least 30 × 10^9/L and a 2-fold increase from baseline in platelet count during the DBTP | Up to 24 weeks | |
| Secondary | Number of cumulative weeks during the DBTP with platelet counts of at least 30 × 10^9/L and ≥20 × 10^9/L above baseline | Up to 24 weeks | |
| Secondary | Number of cumulative weeks during the DBTP with platelet counts of at least 30 × 10^9/L and at least 20 × 10^9/L above baseline in participants with baseline platelet counts of <15 × 10^9/L | Up to 24 weeks | |
| Secondary | Extent of disease control, defined as the percentage of weeks with platelet counts of at least 50 × 10^9/L | Up to 76 weeks | |
| Secondary | In participants receiving placebo IV in the DBTP, the extent of disease control, defined as the number of cumulative weeks with platelet counts of at least 50 × 10^9/L | Up to 76 weeks | |
| Secondary | Overall platelet count response, defined as the proportion of participants achieving a platelet count of at least 50 × 10^9/L on at least 4 occasions during the first 52 weeks of treatment with efgartigimod IV | Up to 52 weeks | |
| Secondary | Mean change from baseline in platelet count at each study visit | Up to 76 weeks | |
| Secondary | The percentage of weeks with platelet counts of at least 30 × 10^9/L and at least 20 × 10^9/L above baseline | Up to 76 weeks | |
| Secondary | In participants with baseline platelet counts <15 × 10^9/L, the percentage of weeks with platelet counts of at least 30 × 10^9/L and at least 20 × 10^9/L above baseline | Up to 76 weeks | |
| Secondary | Proportion of participants who achieve a sustained platelet count response, defined as achieving platelet counts of at least 50 × 10^9/L for at least 4 occasions during 6-week intervals | Up to 76 weeks | |
| Secondary | In participants receiving placebo IV in the DBTP, the proportion of participants achieving platelet counts of at least 50 × 10^9/L for at least 8 of the 12 study visits between weeks 13 and 24 of the OLTP1 | Up to 12 weeks | |
| Secondary | In participants receiving placebo IV in the DBTP, proportion of participants who achieve sustained platelet count response, defined as achieving platelet counts of at least 50 × 10^9/L for at least 6 of 8 visits between weeks 17 and 24 of the OLTP1 | Up to 8 weeks |
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/NCT06544499/registered