Trial · NCT03275454
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events | Up to 97 weeks | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Primary | Number of Participants With Premature Study Terminations | Approximately 97 weeks | Number of participants with premature study terminations will be assessed. |
| Primary | Number of Participants With Clinical Laboratory Abnormalities | Approximately 97 weeks | Clinical laboratory abnormalities including one or more specific target-organs for toxicity of BIVV009, abnormalities in D-dimer, thrombin-anti-thrombin assay, and Systemic Lupus Erythematosus (SLE) panel. |
| Secondary | Part A: Change From Baseline in Peripheral Blood Platelet Count at Part A End of Treatment (A-EOT) | Baseline and A-EOT (Day 147) | Change from baseline in peripheral blood platelet count at A-EOT will be assessed. |
| Secondary | Part A: Change From Baseline in Peripheral Blood Platelet Count during BIVV009 Treatment | Baseline up to Day 147 | Change from baseline in peripheral blood platelet count during BIVV009 treatment will be assessed. |
| Secondary | Part A: Number of Participants who are independent from using combination Immune Thrombocytopenia (ITP) therapy during A-EOT but receive combination ITP therapy after A-EOT | Day 147 (A-EOT) up to Day 196 (EOS) | Number of participants who are independent from using combination ITP therapy during A-EOT but receive combination ITP therapy after A-EOT will be assessed. |
| Secondary | Part A: Number of Participants who Achieve Complete Response Through A-EOT | Up to Day 147 | Complete response (CR) is defined as a platelet count greater than or equal to (\>=) 100\*10\^9/liter (L) measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits. |
| Secondary | Part A: Number of Participants who Achieve Response Through A-EOT | Up to Day 147 | Response or Better: Response (R) is defined as a platelet count \>= 30\*10\^9/L and a greater than 2-fold increase from baseline measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits; and CR: A platelet count \>=100\*10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits. |
| Secondary | Part A: Duration of Complete Response per Each CR | Up to Day 196 | Duration of CR is defined as the number of consecutive days in which a patient's peripheral blood platelet count is \>= 100\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy. |
| Secondary | Part A: Duration of Response per Each Response | Up to Day 196 | Duration of response is defined as the number of consecutive days in which a patient's peripheral blood platelet count is \>= 30\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy. |
| Secondary | Part A: Time to First Platelet Response | Up to Day 196 | Time to first platelet response is defined as greater than or equal to 30\*10\^9/L, 50\*10\^9/L, 100\*10\^9/L (confirmed by a consecutive platelet response at least 7 days apart). |
| Secondary | Part A: Number of Participants who Report Loss of Response Among Those who Achieve Response | Up to Day 196 | Number of participants who report loss of response among those who achieve response will be reported. For a participant with a response (R), the loss of the response is defined as a platelet count \< 30\*10\^9/L measured on 2 consecutive occasions at least 1 day apart, or a less than 2-fold increase in platelet count from baseline measured on 2 consecutive occasions at least 1 day apart, or the presence of bleeding, or use of the combination ITP therapy. |
| Secondary | Part A: Number of Participants who Report Loss of Complete Response Among Those who Achieve Complete Response | Up to Day 196 | Number of participants who report loss of complete response among those who achieve complete response will be reported. For a participant with a complete response (CR), loss of complete response is defined as a platelet count less than (\<) 100\*10\^9/L measured on 2 consecutive occasions more than 1 day apart and/or the presence of bleeding or use of the combination ITP therapy. |
| Secondary | Part B: Change From Baseline in Peripheral Blood Platelet Count to B-EOT | Baseline up to 52 weeks | Change from baseline (Part B) in peripheral blood platelet count to B-EOT will be assessed. |
| Secondary | Part B: Number of Participants who Achieve CR and the Lack of Platelet Transfusions or Other ITP Therapy During Treatment Period | Up to 52 weeks | Number of participants who achieve CR and the lack of platelet transfusions or other ITP therapy during Part B treatment period will be reported. Complete response (CR): A platelet count \>= 100\*10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits. |
| Secondary | Part B: Number of Participants who Achieve Response Through Part B End of Treatment (B-EOT) | Up to 52 weeks | Number of participants who achieve response through B-EOT will be reported. |
| Secondary | Part B: Duration of Complete Response per Each CR | Up to 52 weeks | Duration of CR is defined as the number of consecutive days in which a participant's peripheral blood platelet count is \>= 100\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy. |
| Secondary | Part B: Duration of Response per each Response | Up to 52 weeks | Duration of response is defined as the number of consecutive days in which a participant's peripheral blood platelet count is \>= 30\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy. |
| Secondary | Part B: Number of Participants who achieve a platelet count >= 100*10^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT | Up to 52 weeks | Number of participants who achieve a platelet count \>= 100\*10\^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed. |
| Secondary | Part B: Number of Participants who achieve a platelet count >=30*10^9/L, a >2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart, have absence of bleeding on and through these two visits, use any combination ITP therapy | Up to 52 weeks | Number of participants who achieve a platelet count \>= 30\*10\^9/L and a greater than (\>) 2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed. |
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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