SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00056550

Developed by Shray Alag, 2019.
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 12
THBD F2 PIEZO1 PROC F5 PROS1 SERPIND1 PMM2 SERPINC1 F9 AKT1 PLAT
Reduced antithrombin III activity
Genes 10
PGM1 DPAGT1 MGAT2 ALG6 DPM1 PMM2 SRD5A3 SERPINC1 AHCY MPI
Venous thrombosis
Genes 74
MPL IL10 JAK2 TET2 IL12A EPOR MET PRSS1 USP8 PRSS2 SAA1 THBD PDE4D PRTN3 THPO HLA-B SPINK1 SH2B3 PDGFRA ERAP1 HLA-DPA1 CALR IL12A-AS1 HLA-DPB1 PIEZO1 CFTR TLR4 CTRC FGA CD55 FGB PRKAR1A AGGF1 CDH23 CPA1 SERPINC1 CASR CCR1 UBAC2 AKT1 PTPN22 PLAT C4A CTLA4 GNAQ IDH1 FGG IDH2 CTNNB1 ACVRL1 PTEN GDF2 FAS F2 HBB ENG F5 CBS SERPIND1 KLRC4 F9 PTH1R MEFV IL23R NOTCH1 PGM1 TP53 STAT4 KIF11 PROC SMAD4 PROS1 PMM2 PIGM