Trial · NCT04274452
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of cumulative weeks over the planned 24 week treatment period with platelet counts of ≥50×10^9/L in patients with chronic ITP. | Up to 24 weeks | |
| Secondary | Number of cumulative weeks over the planned 24-week treatment period with platelet counts of ≥50×10^09/L in the overall population (chronic and persistent ITP). | Up to 24 weeks | |
| Secondary | Proportion of patients in the overall population with a sustained platelet count response defined as achieving platelet counts of ≥50×10^9/L for at least 4 of the 6 visits between week 19 and 24 of the trial | Up to 6 weeks | |
| Secondary | Proportion of patients in the overall population achieving platelet counts of ≥50×10^9/L for at least 6 of the 8 visits between week 17 and 24 of the trial | Up to 8 weeks | |
| Secondary | Proportion of patients in the overall population with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time during the treatment period | Up to 24 weeks | |
| Secondary | Extent of disease control defined as the number of cumulative weeks until week 12, with platelet counts of ≥50×10^9/L in the overall population | Up to 12 weeks | |
| Secondary | Proportion of patients in the overall population with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time until week 12 | Up to 12 weeks | |
| Secondary | Mean change from baseline in platelet count at each visit in the overall population. | Up to 31 weeks | |
| Secondary | Time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10^9/L in the overall population | Up to 31 weeks | |
| Secondary | The number of cumulative weeks over the treatment period with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline in the overall population | Up to 24 weeks | |
| Secondary | In patients with baseline platelet count of <15×10^9/L, the number of cumulative weeks over the treatment period with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline in the overall population | Up to 31 weeks | |
| Secondary | Incidence and severity of the World Health Organization (WHO)-classified bleeding events in the overall population | Up to 31 weeks | |
| Secondary | Rate of receipt of rescue therapy (rescue per patient per month) | Up to 31 weeks | |
| Secondary | Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have increased at week 12 or later | Up to 24 weeks | |
| Secondary | Incidence and severity of adverse events (AEs), AEs of special interest (AESIs)and serious AEs (SAEs). | Up to 31 weeks | |
| Secondary | Vital signs, electrocardiogram (ECG), and laboratory assessments | Up to 31 weeks | |
| Secondary | Change from baseline in PRO (FACIT-Fatigue, Fact-Th6) at planned visits | Up to 31 weeks | |
| Secondary | Change from baseline in QoL (SF-36) at planned visits | Up to 31 weeks | |
| Secondary | Incidence of anti-drug antibodies (ADA) to efgartigimod | Up to 31 weeks | |
| Secondary | Pharmacokinetic parameters of efgartigimod : maximum observed serum concentration (Cmax) | Up to 31 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.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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04274452/registered