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Report for Clinical Trial NCT00056550

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.

Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

NCT00056550 Antithrombin Deficiency, Congenital
MeSH: Thrombosis Venous Thrombosis Antithrombin III Deficiency
HPO: Deep venous thrombosis Reduced antithrombin III activity Venous thrombosis

1 Interventions

Name: Recombinant Human Antithrombin (rhAT)

Description: Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.

Type: Biological

Recombinant Human Antithrombin (rhAT) infusion


Primary Outcomes

Description: Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).

Measure: Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).

Time: Baseline, last day of dosing and day 7 (+ or - 1 day)

Secondary Outcomes

Description: The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.

Measure: Local Assessment of Thromboembolism by Physical Examination.

Time: 30 days after last dose

Purpose: Prevention

Single Group Assignment


There is one SNP

SNPs


1 G20210A

Exclusion Criteria: - Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder. --- G20210A ---



HPO Nodes


HPO:
Deep venous thrombosis
Genes 17
PROC HABP2 F5 SERPINC1 PMM2 F2 AKT1 SERPIND1 SERPINC1 PIEZO1 PROS1 MTHFR PROC THBD F13A1 PLAT F9
Reduced antithrombin III activity
Genes 14
DPAGT1 AHCY SERPINC1 PMM2 ALG6 SERPINC1 MGAT2 DPM1 PMM2 DPM2 SRD5A3 SRD5A3 MPI PGM1
Venous thrombosis
Genes 96
HLA-DPA1 FGA GDF2 MPL TLR4 PTPN22 MET SPINK1 FGG SERPINC1 AKT1 STAT4 CCR1 PROS1 TP53 SAA1 CBS TET2 GNAQ IDH1 FGB JAK2 ACVRL1 IDH2 F5 SERPINC1 CPA1 GNAQ F2 AKT1 SERPIND1 PDGFRA CTRC NOTCH1 JAK2 HBB PROS1 PIEZO1 ERAP1 AGGF1 CDH23 PROC HLA-DPB1 THBD KIF11 F13A1 KLRC4 TET2 IL10 PROS1 UBAC2 PIGM HLA-B IDH2 PROC HABP2 MPL MPL CD55 C4A SMAD4 IL12A-AS1 THPO CALR IL12A CALR IL23R JAK2 HBB CTNNB1 PLAT F9 PRSS1 MEFV TET2 PMM2 IDH1 PTEN CTLA4 PTH1R CASR SH2B3 USP8 MTHFR PROC PRTN3 MPL FAS EPOR CFTR PRKAR1A PDE4D PRSS2 ENG JAK2 PGM1