Trial · NCT07194850
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
NCT07194850, Phase 2, Phase 3, Recruiting, argenx
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP). Trials, record NCT07194850. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07194850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
- NCT number
- NCT07194850
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 24 participants, estimated
- Lead sponsor
- argenx
- Conditions
Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITP, Immune Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura ( ITP ), Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura (ITP)
- Interventions
- Efgartigimod IV, Placebo IV
- First posted
- 2025-09-26
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07194850
GET https://conductscience.org/api/trials/v1/NCT07194850/registered