Trial · NCT05148299
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pegcetacoplan Pharmacokinetic (PK) Parameter Area Under the Curve Limited to the End of Dosing Interval (AUC0-tau) | Week 1 | Area under the concentration-time curve limited to the end of the dosing interval. The samples included in the calculation of AUC0-tau were collected at the following times: on dosing Days 1, 3 and 5, PK samples were taken up to 30 minutes pre-dose and at 15 minutes (± 5 min), 30 minutes (± 5 min), 1 hour (± 10 min), 4 hours (± 10 min), 8 hours (± 30 min), and 24 hours (± 30 min) post-dose as well as on Day 8 pre-dose. |
| Primary | Pegcetacoplan PK Parameter Maximal Serum Concentration (Cmax) | Week 1 | Maximum observed serum concentration. Determined using the samples collected post-dose on dosing Days 1, 3 and 5. |
| Primary | Pegcetacoplan PK Parameter Time to Cmax (Tmax) | Week 1 | Time of maximum measured serum concentration. Determined using the samples collected post-dose on dosing Days 1, 3 and 5. |
| Primary | Pegcetacoplan PK Parameter Observed Serum Concentration Pre-dose (Ctrough) | Week 1 up to Week 14 | Observed serum concentration pre-dose. From Day 8 (Week 1) and onwards, PK samples were taken pre-dose at each visit. |
| Secondary | Absolute Levels and Change From Baseline in sC5b-9 | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation sC5b-9 |
| Secondary | Absolute Levels and Change From Baseline in C3a | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation C3a |
| Secondary | Absolute Levels and Change From Baseline in C3 | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation C3 |
| Secondary | Absolute Levels and Change From Baseline in Bb | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation Bb |
| Secondary | Absolute Levels and Change From Baseline in C4a | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation C4a |
| Secondary | Absolute Levels and Change From Baseline in Classical Pathway (CH50) | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation CH50 |
| Secondary | Absolute Levels and Change From Baseline in Alternative Pathway (AH50) | Week 24 | Absolute levels and change from baseline to Week 24 in biomarker of complement activation AH50 |
| Secondary | Number of Participants Reaching Clinical Response at Week 24 | Week 24 | A participant will be declared as reaching a clinical response upon improvement in laboratory markers of TMA and resolution of TMA clinical symptoms |
| Secondary | Number of Participants Reaching TMA Response at Week 24 | Week 24 | A participant will be declared as reaching TMA response upon improvement in laboratory markers of TMA |
| Secondary | Overall Survival at Day 100 | Day 100 from diagnosis | Survival |
| Secondary | Overall Survival at Week 24 | Week 24 from treatment start | Survival |
| Secondary | Time to Clinical Response | From treatment start to first documentation of attainment of a clinical response, up to 24 weeks | Both clinical response sustained at week 24 and clinical response at any time during the study will be assessed. |
| Secondary | Time to TMA Response | From treatment start to first documentation of attainment of a TMA response, up to 24 weeks | Both TMA response sustained at week 24 and TMA response at any time during the study will be assessed. |
| Secondary | Duration of Clinical Response | From the first observed clinical response until the response criteria is no longer fulfilled or until end of study, up to 24 weeks | Duration of clinical response sustained at week 24 |
| Secondary | Duration of TMA Response | From the first observed TMA response until the response criteria is no longer fulfilled or until end of study, up to 24 weeks | Duration of TMA response sustained at week 24 |
| Secondary | TA-TMA Relapse at Week 24 | Week 24 | A participant will be declared as relapsing upon appearance of laboratory markers of TMA |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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