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All-Case Surveillance of Prizbind®
trial testing Prizbind® in Hemorrhage in 1,402 participants. Completed in 3 November 2020.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,402 |
| Start date | 18 November 2016 |
| Primary completion | 3 November 2020 |
| Estimated completion | 3 November 2020 |
| Sites | 1 location across Japan |
Boehringer Ingelheim — full company profile →
18 and older, any sex, with Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
| Group | Value | 95% CI |
|---|---|---|
| Prizbind® for Intravenous Solution | 30 |
Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.
| Group | Value | 95% CI |
|---|---|---|
| Prizbind® for Intravenous Solution | 100.0 | 82.50 – 100.0 |
Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100. Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50%
| Group | Value | 95% CI |
|---|---|---|
| Prizbind® for Intravenous Solution | 65 | |
| Prizbind® for Intravenous Solution | 16 | |
| Prizbind® for Intravenous Solution | 9 | |
| Prizbind® for Intravenous Solution | 13 |
Time frame: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Prizbind® for Intravenous … |
|---|---|---|
| Pneumonia aspiration | Infections and infestations | — |
| Subdural haematoma | Injury, poisoning and procedural complications | — |
| Cerebral infarction | Nervous system disorders | — |
| Cerebral haemorrhage | Nervous system disorders | — |
| Shock haemorrhagic | Vascular disorders | — |
| Brain oedema | Nervous system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Seizure | Nervous system disorders | — |
| Epilepsy | Nervous system disorders | — |
| Haemorrhage | Vascular disorders | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Peritonitis | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Embolic stroke | Nervous system disorders | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Brain herniation | Injury, poisoning and procedural complications | — |
| Extradural haematoma | Injury, poisoning and procedural complications | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Cerebellar haemorrhage | Nervous system disorders | — |
| Arterial occlusive disease | Vascular disorders | — |
| Circulatory collapse | Vascular disorders | — |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Pneumonia aspiration, Subdural haematoma, Cerebral infarction, Cerebral haemorrhage, Shock haemorrhagic, Brain oedema, Cardiac failure, Seizure.
Data from ClinicalTrials.gov NCT02946931 adverse events section.
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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