Last reviewed · How we verify
NCT02798107
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
trial testing idarucizumab in Hemorrhage. Withdrawn.
23 May 2019
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 20 May 2019 |
| Primary completion | 23 May 2019 |
| Estimated completion | 24 May 2019 |
Drugs / interventions tested
- idarucizumab (IDARUCIZUMAB) — full drug profile →
Conditions studied
- Hemorrhage — all drugs for Hemorrhage →
Sponsor
Boehringer Ingelheim — full company profile →
Who can join
Under 17, any sex, with Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evidence for Idarucizumab (Praxbind) in the Reversal Of the Direct Thrombin Inhibitor Dabigatran: Review Following the RE-VERSE AD Full Cohort Analysis.
Hutcherson TC, Cieri-Hutcherson NE, Bhatt R. · · 2017 · cited 6× · PMID 29089725
Verify or expand the search:
- PubMed search for NCT02798107
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of idarucizumab
Trials testing the same drug.
- NCT02831660 — CU Programme of Idarucizumab for Japanese Patients · Phase 3 · completed
- NCT02104947 — Reversal of Dabigatran Anticoagulant Effect With Idarucizumab · Phase 3 · completed
Other recruiting trials for Hemorrhage
Currently open trials in the same condition.
- NCT07311343 — Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia · Phase 4 · recruiting
- NCT07105904 — Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery · active not recruiting
- NCT06979466 — Q Therapeutic System for Chronic Stroke Recovery · NA · recruiting
- NCT06664775 — A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate S · Phase 3 · recruiting
- NCT06304714 — Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02798107 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 18 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02798107.
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