Trial · NCT04812925
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
NCT04812925, Phase 3, Active not recruiting, argenx
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia. Trials, record NCT04812925. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04812925
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
- NCT number
- NCT04812925
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 173 participants, actual
- Lead sponsor
- argenx
- Conditions
- Primary Immune Thrombocytopenia
- Interventions
- efgartigimod PH20 SC
- First posted
- 2021-03-24
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of AEs, AESIs, SAEs | Up to 216 weeks | AE : adverse event ; SAE : Serious adverse event ; AESI : adverse event of special interest. |
| Primary | Vital sign measurement: blood pressure in the overall population | Up to 216 weeks | |
| Primary | ECG: PR, QT and QRS interval in the overall population | Up to 216 weeks | |
| Primary | Laboratory safety evaluations: CRP analysis in the overall population | Up to 216 weeks | |
| Secondary | Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10E9/L | Up to 52 weeks | |
| Secondary | Proportion of participants with overall platelet count response defined as achieving a platelet count of ≥50×10E9/L on at least 4 occasions at any time during the 52-week treatment period | Up to 52 weeks | |
| Secondary | Mean change from baseline in platelet count at each visit | Up to 52 weeks | |
| Secondary | For participants rolling over from the ARGX-113-2004 trial with a platelet count of <30×10E9/L: time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10E9/L | Up to 52 weeks | |
| Secondary | The percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline | Up to 52 weeks | |
| Secondary | In patients with a baseline platelet count of <15×10E9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of ≥30×10E9/L and ≥20×10E9/L above baseline | Up to 52 weeks |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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/NCT04812925
GET https://conductscience.org/api/trials/v1/NCT04812925/registered?page=2