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NCT03809481: HITSOVA

Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban

Terminated Phase 3 Last updated 8 December 2022
What this trial tests

Phase 3 trial testing Danaparoid Sodium in Heparin-induced Thrombocytopenia in 7 participants. Terminated before completion.

Timeline
16 May 2019
Primary endpoint
10 June 2022
10 June 2022

Quick facts

Lead sponsorAspen Global Incorporated
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment7
Start date16 May 2019
Primary completion10 June 2022
Estimated completion10 June 2022
Sites35 locations across Bosnia and Herzegovina, France, Italy, Russia, Serbia, Germany, Poland, Canada

Drugs / interventions tested

Conditions studied

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.

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Other Aspen Global Incorporated trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing