Trial · NCT03275454
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 33 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Part B: Number of Participants who do not Require Other Immune Thrombocytopenia (ITP) Therapy (non-transfusion) During the Part B Treatment Period | Up to 52 weeks | Number of Participants who do not require other ITP therapy (non-transfusion) following the last BIVV009 dose will be assessed. |
| Secondary | Part B: Number of Participants who do not Require Platelet Transfusions During the Part B Treatment Period | Up to 52 weeks | Number of Participants who do not require platelet transfusions during the Part B treatment period will be reported. |
| Secondary | Part B: Number of Participants who Experience any Bleeding Episode, Bleeding by Grade or Serious Bleeding | Up to 52 weeks | Number of participants who experience any bleeding episode, bleeding by grade or serious bleeding according to the International Working Group (IWG) Bleeding Assessment Tool (BAT) will be reported. |
| Secondary | Plasma Concentrations of BIVV009 | Approximately 97 weeks | Plasma concentrations of BIVV009 will be assessed. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of BIVV009 | Approximately 97 weeks | Maximum observed concentration of BIVV009 in plasma will be assessed. |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009 | Approximately 97 weeks | Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009 will be assessed. |
| Secondary | Area Under the Concentration-time Curve (AUC) From Hour 0 to the last quantifiable time point (AUC [0-t]) of BIVV009 | Approximately 97 weeks | AUC (0-t) is the area under the Concentration-time curve (AUC) from hour 0 to the last quantifiable time point of BIVV009. |
| Secondary | Number of Participants With Anti-drug antibodies (ADAs) Against BIVV009 | Up to 97 weeks | Blood samples will be collected to determine number of participants with anti-drug antibodies (ADAs) against BIVV009. |
| Secondary | Complement System Classical Pathway Levels as Measured by WIESLAB Assay | Up to 97 weeks | Inhibition by BIVV009 of the complement system classical pathway measured by the WIESLAB assay. |
| Secondary | Total Complement (CH50) Levels | Up to 97 weeks | Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays. |
| Secondary | Total Complement Factor C4 Levels | Up to 97 weeks | Total C4 Levels will be assessed in plasma using complement assays. |
| Secondary | C1 Complex Components: C1q | Up to 97 weeks | C1q Levels will be assessed in plasma using complement assays. |
| Secondary | Thrombopoietin Level | Up to 97 weeks | Thrombopoietin level will be assessed in plasma using complement assays. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03275454/registered?page=2