Trial · NCT03124368
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline In Serum C3 Complement Protein (C3) Levels On Day 15 | Baseline, Day 15 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | g/L | MEAN |
| PRIMARY | Change From Baseline In Plasma Intact C3 Level On Day 15 | Baseline, Day 15 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | μg/mL | MEAN |
| SECONDARY | Change From Baseline In Total Complement Classical Pathway (CP) Activity On Day 14 | Baseline, Day 14 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | CAE unit | MEAN |
| SECONDARY | Change From Baseline In Total Complement Alternative Pathway (AP) Functional Activity (AP Wieslab) On Day 15 | Baseline, Day 15 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | percentage of activity | MEAN |
| SECONDARY | Time To Achieving Peak Serum C3 Levels | From The First Day Of Dosing through Day 14 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | days | MEAN |
| SECONDARY | Number Of Participants With Serious Adverse Events (SAEs), Grade 3 And Grade 4 Treatment-emergent Adverse Events (TEAEs), And Adverse Events (AEs) Leading To Discontinuation | Up to Day 49 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Area Under The Plasma Concentration-time Curve From Time Of Administration To 8 Hours Postdose (AUC0-8) | Days 1 and 7 | All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Maximum Plasma Concentration (Cmax) | Days 1 and 7 | All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Time To Maximum Concentration (Tmax) | Days 1 and 7 | All participants receiving at least 1 dose of danicopan who had a baseline measurement and at least 1 measurement during the treatment period. | hours | MEDIAN |
| SECONDARY | Change From Baseline In Bb Fragment Of Complement Factor B (Bb) At Day 15 | Baseline, Day 15 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | µg/mL | MEAN |
| SECONDARY | Change From Baseline In Soluble Terminal Complement Complex (sC5b-9) At Day 15 | Baseline, Day 15 | All participants who received at least 1 dose of danicopan and who had a baseline measurement and at least 1 measurement during the treatment period. | ng/mL | MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03124368/outcomes