Trial · NCT07194850
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efgartigimod serum concentrations in the DBTP | Up to 24 weeks | |
| Primary | Total IgG levels in the DBTP | Up to 24 weeks | |
| Secondary | Efgartigimod serum concentrations over time during the DBTP | Up to 24 weeks | |
| Secondary | Percent change from baseline in total IgG levels in serum over time during the DBTP | Up to 24 weeks | |
| Secondary | Incidence of AEs, SAEs and AEs leading to IMP discontinuation | Up to 136 weeks | SAE: Serious adverse event; AE: adverse event |
| Secondary | Sustained platelet count response between study weeks 19 and 24 of the DBTP and in OLTP1 for participants receiving placebo in the DBTP | Up to 48 weeks | Sustained platelet count defined as achieving platelet counts of ≥50 × 10\^9/L for at least 4 of the 6 study visits |
| Secondary | Extent of disease control during the DBTP and during the first 24 weeks of OLTP1 for those participants receiving placebo in the DBTP | Up to 48 weeks | Extend of disease defined as the number of cumulative weeks with a platelet count of ≥50 × 10\^9/L |
| Secondary | Changes from baseline for platelet counts over time | Up to 76 weeks | |
| Secondary | Incidence of bleeding, assessed by the Modified Buchanan and Adix Bleeding Score for pediatric ITP | Up to 76 weeks | The Modified Buchanan and Adix Bleeding Score for pediatric ITP is a semiquantitative assessment tool that measures bleeding signs and symptoms, comprising a score based on a scale of 0 to 5, each representing a different level of severity (0 = no risk; 5 = highest severity). |
| Secondary | Incidence of ADA and Nab against efgartigimod in serum | Up to 76 weeks | ADA: anti-drug antibodies; Nab: neutralizing antibodies |
| Secondary | Change from baseline in EQ-5D-5L | Up to 76 weeks | The European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) is a questionnaire comprised of 5 dimensions. Participants are asked to select the statement in each dimension which best describes their health on the day they complete the questionnaire. Responses in each dimension are coded as a 1-digit number ranging from 1 (no problems) to 5 (extreme problems). |
| Secondary | Change from baseline in KIT Child Self-Report and KIT Parent Impact Report | Up to 76 weeks | The Kids' ITP Tools (KIT) comprises two disease- specific tools: a self-report form for children aged 12 and older, and a parent impact form. Respondents provide insights into their disease experience using a 1-week recall period. The instrument generates a total score, calculated by summing the items and converting them to a scale of 0 to 100, where higher scores reflect a better disease-specific quality of life (QoL). |
| Secondary | Change from baseline in peds FACIT-F | Up to 76 weeks | In all participants, the pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) will use to assess health-related quality of life (HRQoL) before and after treatment. The FACIT-F questionnaire has a score range of 0 to 52, where 0 represents the worst possible fatigue and 52 indicates no fatigue. |
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.
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GET https://conductscience.org/api/trials/v1/NCT07194850/registered