Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

LEO Pharma

Status and phase: Terminated; Phase 2

Conditions: Disseminated Intravascular Coagulation

Treatments: Drug: Control (Standard treatment); Drug: Antithrombin alfa (INN name)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506519

LEO 90010-I21

Details and patient eligibility

About

The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Signed informed consent has been obtained from the patient or his/her legally acceptable representative
• Severe sepsis
• Disseminated intravascular coagulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

AT-150

Experimental group

Description:

Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%

Treatment:

Drug: Antithrombin alfa (INN name)

AT-250

Experimental group

Description:

Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%

Treatment:

Drug: Antithrombin alfa (INN name)

Control

Active Comparator group

Description:

The best standard treatment for the underlying condition only

Treatment:

Drug: Control (Standard treatment)