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Atryn Medical Research Studies

Up-to-date List of Atryn Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Atryn Medical Research Studies

Rank Status Study
1 Recruiting Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
Condition: Preeclampsia
Intervention: Biological: Recombinant human antithrombin (Atryn)
Outcome Measures: The primary outcome measure is the increase in gestational age.;   The secondary outcome measure is a composite measure of specific fetal and neonatal outcomes.
2 Unknown  Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Conditions: Aortic Valve Insufficiency;   Aortic Valve Stenosis;   Mitral Valve Insufficiency;   Mitral Valve Stenosis;   Acute Coronary Syndrome
Intervention: Drug: antithrombin III
Outcome Measures: Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.;   Number of participants with infection as a measure of safety.;   Number of participants with delirium as a measure of safety.;   Number of participants with wound complication as a measure of safety.;   Number of participants with multi organ failure as a measure of safety.
3 Recruiting Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
Condition: Cardiopulmonary Bypass
Interventions: Drug: Antithrombin III;   Other: Saline Placebo
Outcome Measures: Chest tube volume loss;   Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass;   Blood product transfusions intra-operatively and for the first 24 hours following surgery;   Clinical outcomes;   Intraoperative coagulation profile;   Post-operative markers of platelet activation;   Use of recombinant factor VIIa after surgery to control post-operative bleeding
4 Recruiting Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Condition: Hepatic Veno-Occlusive Disease
Intervention: Drug: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Outcome Measures: AT-III level before 5th dose of AT-III;   AT-III level before 9th dose
5 Not yet recruiting Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
Conditions: Cardiac Surgery;   Cardiopulmonary Bypass
Interventions: Biological: AT-III (Human);   Other: Placebo
Outcome Measure: Percentage of subjects with any component of a major morbidity composite
6 Not yet recruiting Anti-thrombin III (ATIII) vs Placebo in Children (<6mo) Undergoing Open Congenital Cardiac Surgery
Condition: ATIII Deficiency
Interventions: Drug: Anti-thrombin III;   Other: Placebo
Outcome Measures: Decreased activation of the coagulation and fibrinolytic systems;   Total dose of heparin and protamine;   Total volume of blood products;   Time from protamine administration to skin dressing;   Volume of postoperative blood loss;   Volume of blood products;   Use of recombinant factor VIIa;   Safety profile of ATIII dosing;   Length of post operative ventilation
7 Recruiting Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)
Condition: Congenital Heart Disease
Interventions: Drug: Antithrombin III;   Drug: Placebo
Outcome Measures: The primary hypothesis is that treatment with ATIII before bypass will decrease the activation of inflammation during CPB as measured by plasma neutrophil elastase.;   p-selectin;   interleukin-6;   prothrombin fragment 1.2;   24 hour blood loss;   ICU length of stay;   Hospital length of stay
8 Recruiting Understanding "Heparin Resistance" in Cardiac Surgery
Conditions: Cardiopulmonary Bypass;   Altered Heparin Response
Interventions: Drug: Heparin;   Drug: Atryn
Outcome Measures: Altered Heparin Responsivness (AHR);   "True Heparin Resistance"
9 Recruiting Safety, Pharmacokinetics and Efficacy of an AT-III Concentrate.
Condition: Antithrombin III Deficiency
Intervention: Drug: Plasma-derived AT-III concentrate
Outcome Measures: The primary objectives of this clinical study are to:;   Assess the pharmacokinetic (PK) profile of AT-III in congenital AT-III deficient patients;   To measure the in vivo recovery and half-life of AT-III.;   To assess the clinical safety and tolerability of AT-III-DAF/DI.;   To assess clinical efficacy by preventing thromboembolic or thrombotic events (prophylaxis) in individuals with congenital AT-III deficiency who are undergoing surgical procedures or who are pregnant and undergoing parturition.
10 Recruiting Prevention of Thrombosis Recurrence in Patients With Low Circulating Levels of Antithrombin.
Condition: Venous Thrombosis
Intervention: Drug: long-lasting OAT or 12-month OAT
Outcome Measures: VTE recurrence during the 8-year follow-up;   Bleeding events during the 8-year follow-up
11 Recruiting Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers
Condition: Reperfusion Injury
Interventions: Drug: Antithrombin-III;   Drug: Infliximab;   Drug: Apotransferrin;   Drug: Human recombinant erythropoietin;   Drug: C1-Inhibitor;   Drug: Glutathione;   Drug: Alfa-tocopherol;   Drug: Melatonin;   Drug: Epoprostenol
Outcome Measure: Number of participants with adverse events
12 Recruiting A Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of PF-05280602, A Recombinant Factor VIIa Variant (813d), In Adult Subjects With Hemophilia A Or B
Condition: Hemophilia A
Intervention: Biological: PF-05280602
Outcome Measures: Incdence of subjects wtih treatment emergent adverse events;   Incidence of of subjects with treatment emergent hemophilia adverse events;   Incidence of subjects with treatment emergent serious adverse events;   Changes from baseline in patient's vital signs- blood pressure;   Changes from baseline in patient's ECG;   Changes from baseline in patient's physical examination;   Incidence of treatment emergent clinical laboratory abnormalities for Tropin T levels;   Magnitude of treatment emergent clinical laboratory abnormalities for Troponin T levels;   Incidence of an immune response;   Incidence of treatment emergent clinical laboratory abnormalities for Anti-Thrombin III;   Incidence of treatment emergent clinical laboratory abnormalities for Tissue Factor Pathway Inhibitor;   Number of subjects with clinically significant changes from baseline in their fibrinogen;   Changes from baseline in patient's vital signs- weight;   Changes from baseline in patient's vital signs- temperature;   Changes from baseline in patient's vital signs- respiration rate;   Changes from baseline in patient's vital signs- pulse rate;   Severity of subjects wtih treatment emergent adverse events;   Severity of of subjects with treatment emergent hemophilia adverse events;   Severity of subjects with treatment emergent serious adverse events;   Withdrawals due to treatment emergent adverse events;   Withdrawals due to treatment emergent hemophilia events;   Incidence of treatment emergent clinical laboratory abnormalities for hematology;   Magnitude of treatment emergent clinical laboratory abnormalities for hematology;   Incidence of treatment emergent clinical laboratory abnormalities for chemistry;   Magnitude of treatment emergent clinical laboratory abnormalities for chemistry;   Incidence of treatment emergent clinical laboratory abnormalities for urinalysis;   Magnitude of treatment emergent clinical laboratory abnormalities for urinalysis;   Incidence of treatment emergent clinical laboratory abnormalities for platelet count;   Magnitude of treatment emergent clinical laboratory abnormalities for platelet count;   Magnitude of treatment emergent clinical laboratory abnormalities for Anti-Thrombin III;   Magnitude of treatment emergent clinical laboratory abnormalities for Tissue Factor Pathway Inhibitor;   Incidence of treatment emergent clinical laboratory abnormalities for C-Reactive Protein;   Magnitude of treatment emergent clinical laboratory abnormalities for C-Reactive Protein;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, Cmax;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, area under the curve (AUC last);   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, terminal half-life;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, recovery;   Pharmacodynamic (Hematologic) activity as measured by the Prothrombin Time;   Pharmacodynamic (Hematologic) activity as measured by the activated partial thrombinplastin time;   Pharmacodynamic (Hematologic) activity as measured by the thrombin antithrombin complexes;   Pharmacodynamic (Hematologic) activity as measured by the prothrombin fragments 1+2;   Pharmacodynamic (Hematologic) activity as measured by D-Dimers;   Pharmacodynamic (Hematologic) activity as measured by thrombin generation;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, area under the curve (AUC inf);   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, mean residence time;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, Vss;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, clearance;   Factor VIIa concentration in subject plasma as measured by FVIIa PK assay, Tmax
13 Recruiting Triple vs. Dual Therapy
Conditions: Atrial Fibrillation;   Acute Coronary Syndrome
Interventions: Drug: Ticagrelor + Apixaban + ASA;   Drug: Ticagrelor + Apixaban
Outcome Measures: β-thromboglobulin (β-TG);   Prothrombin fragment F1+2 (F1+2);   Thrombin-Anti-Thrombin (TAT);   D-dimer;   P-selectin
14 Recruiting Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants
Conditions: Polycystic Ovarian Syndrome;   Hyperandrogenism;   Menstrual Irregularities
Interventions: Drug: 20 mcg ethinylestradiol /3 mg drospirenone;   Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit;   Drug: 30 mcg ethinylestradiol/3 mg drospirenone;   Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit;   Drug: 35 mcg ethinylestradiol/2 mg cyproterone;   Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Outcome Measures: Change from Baseline in Activated recalcification time;   Change from Baseline in Activated partial thromboplastin time;   Change from Baseline in Prothrombin time;   Change from Baseline in International normalized ratio;   Change from Baseline in D-dimer concentration;   Change from Baseline in Fibrinogen concentration;   Change from Baseline in Soluble fibrin-monomer complexes concentration;   Change from Baseline in Platelet aggregation;   Change from Baseline in Antithrombin III activity;   Change from Baseline in Reserve plasminogen index;   Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol;   Change from Baseline in Malondialdehyde Concentration in Erythrocytes;   Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes;   Change from Baseline in Superoxide dismutase Activity in Erythrocytes;   Vitamin A and E plasma concentration;   Frequency of adverse effects;   Subjective tolerability of contraceptives
15 Unknown  Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Condition: Menopause
Interventions: Drug: Isoflavone;   Drug: Placebo
Outcome Measure: Concentration of serum DDimer
16 Recruiting Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA
Conditions: Malfunction; Catheter;   Thrombosis;   Mechanical Complication of Hemodialysis Catheter
Interventions: Drug: rt-PA (2mg/2mL) actilysis;   Drug: rt-PA
Outcome Measures: Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol;   The incidence of catheter-related bacteremia after rt-PA use in case of thrombosed UCs;   Economic evaluation of rt-PA in catheter patency after UCs dysfunction
17 Recruiting A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
Condition: Healthy
Interventions: Biological: PF-05230907;   Drug: Placebo for PF-05230907
Outcome Measures: Incidence of dose limiting treatment related adverse events;   Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events;   Incidence and magnitude of treatment emergent abnormal laboratory findings;   Change from baseline in vital sign measurements, ECG parameters, and physical examinations;   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast);   Maximum Observed Plasma Concentration (Cmax);   Time to Reach Maximum Observed Plasma Concentration (Tmax);   Volume of Distribution at Steady State (Vss);   Systemic Clearance (CL);   Terminal half -life;   Mean residence Time (MRT);   Volume of distribution during terminal phase (Vz);   Area under the curve from time zero to infinity (AUC inf);   Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR);   Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT);   Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes;   Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2);   Pharmacodynamic activity as measured by D-dimer;   Pharmacodynamic activity as measured by protein C activity;   Pharmacodynamic activity as measured by Factor V activity;   Incidence of antibody immune response;   Factor X activity
18 Unknown  Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
Condition: Pharmacodynamics
Intervention: Biological: Suine
Outcome Measures: Effect (activity) of heparin observed for markers for aPTT and anti-Xa.;   Effectiveness in maintaining the absence clotting during hemodialysis.;   Safety in use of the drug by monitoring events complicating the use of heparin
19 Unknown  The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
Condition: Blood Coagulation Disorders
Interventions: Device: Levonorgestrel-containing IUD (Mirena®);   Device: Copper-containing IUD (Paraguard®)
Outcome Measures: The primary outcome of this study will be change in coagulation parameters, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups.;   Patient satisfaction with IUD device;   Difference in bleeding patterns between groups
20 Not yet recruiting Aspirin for Treatment of Severe Sepsis
Condition: Sepsis
Interventions: Drug: aspirin administration;   Drug: placebo
Outcome Measures: reduction of organ dysfunction measured by SOFA score;   lenght of mechanical ventilation

These studies may lead to new treatments and are adding insight into Atryn etiology and treatment.

A major focus of Atryn research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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