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

NCT03809481 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-12-08

No results posted yet for this study

Summary

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)

Conditions

  • Heparin-induced Thrombocytopenia

Interventions

DRUG

Danaparoid Sodium

inhibits thrombin generation by indirect anti-Xa inhibition and direct inhibition of factor IX activation

DRUG

Argatroban

Synthetic direct thrombin inhibitor

Sponsors & Collaborators

  • Aspen Global Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2022-06-10
Completion
2022-06-10
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Russia
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809481 on ClinicalTrials.gov