Trial · NCT03275454
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
NCT03275454, Phase 1, Completed, Bioverativ, a Sanofi company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP). Trials, record NCT03275454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03275454
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
- NCT number
- NCT03275454
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Bioverativ, a Sanofi company
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Interventions
- BIVV009 6.5 grams, BIVV009 7.5 grams
- First posted
- 2017-09-07
- Last updated
- 2023-05-18
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35973190 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03275454
GET https://conductscience.org/api/trials/v1/NCT03275454/registered?page=2