Trial · NCT04812925
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| 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 | |
| Secondary | In participants with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of ≥50×10E9/L for at least 4 of the 6 visits between week 19 and week 24 | 5 weeks (from week 19 to week 24) | |
| Secondary | In participants with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of ≥50×10E9/L for at least 6 of the 8 visits between week 17 and week 24 | 7 weeks (from week 17 to week 24) | |
| Secondary | Proportion of participants for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline | Up to 52 weeks | |
| Secondary | Rate of receipt of rescue therapy (rescue per participant per month) | Up to 52 weeks | |
| Secondary | Incidence of the WHO-classified bleeding events | Up to 52 weeks | WHO : World Health Organization |
| Secondary | Serum efgartigimod concentration observed predose (Ctrough) | Up to 52 weeks | |
| Secondary | Change from baseline in FACIT-fatigue at planned visits | Up to 52 weeks | The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT- fatigue) scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured by recording item responses on a 4-point Likert scale ranging from 0 "not at all" to 4 "very much." |
| Secondary | Change from baseline in FACT-Th6 at planned visits | Up to 52 weeks | The Functional Assessment of Cancer Therapy questionnaire-Th6 (FACT-Th6) uses the Likert scale, with participants rating their degree of concern in the past 7 days. The 6 selected items pertain to ability to do usual activities, worry about problems with bleeding or bruising, worry about the possibility of serious bleeding, avoidance of physical or social activity because of concern with bleeding or bruising and frustration due to the inability to carry out usual activities. |
| Secondary | Change from baseline in SF-36 at planned visits | Up to 52 weeks | The SF-36 is a 36-item scale constructed to survey health-related QoL on 8 domains: limitations in physical activities due to health problems; limitations in social activities due to physical or emotional problems; limitations in usual role activities due to physical health problems; bodily pain; general mental health (psychological distress and well being); limitations in usual role activities due to emotional problems; vitality (energy and fatigue); and general health perceptions. |
| Secondary | Change from baseline in ITP-PAQ at planned visits | Up to 52 weeks | The ITP-Patient Assessment Questionnaire (ITP-PAQ) is a 44-item questionnaire to assess the health-related QoL in adults with ITP. It includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. |
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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