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NCT03809481: HITSOVA
Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban
Phase 3 trial testing Danaparoid Sodium in Heparin-induced Thrombocytopenia in 7 participants. Terminated before completion.
10 June 2022
Quick facts
| Lead sponsor | Aspen Global Incorporated |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 16 May 2019 |
| Primary completion | 10 June 2022 |
| Estimated completion | 10 June 2022 |
| Sites | 35 locations across Bosnia and Herzegovina, France, Italy, Russia, Serbia, Germany, Poland, Canada |
Drugs / interventions tested
- Danaparoid Sodium — full drug profile →
- Argatroban (ARGATROBAN) — full drug profile →
Conditions studied
- Heparin-induced Thrombocytopenia — all drugs for Heparin-induced Thrombocytopenia →
Sponsor
Aspen Global Incorporated
Who can join
Adults 2 Weeks to 100, any sex, with Heparin-induced Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03809481
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other Aspen Global Incorporated trials
Trials by the same sponsor.
- NCT03841396 — A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers. · Phase 4 · completed
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 NCT03809481 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aspen Global Incorporated
- Last refreshed: 8 December 2022
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/NCT03809481.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing