Patients will be randomized (by block randomization) to Desferal (DFO) treatment.

Patients will be randomized (by block randomization) to isotonic saline treatment.

Diabetes Mellitus, Type 1

It is a blinded randomized cross-over study that investigates the efficacy of DFO (50mg/kg) given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.

desferal

It is a blinded randomized cross-over study that investigates the efficacy of isotonic saline given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.

Isotonic saline

Karolinska University Hospital

Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes

The absolute amount of endothelial precursor cells in 10 ml of blood

Sergiu Catrina

Senior consultant / associated professor

This is a randomised, double-blind, placebo-controlled, cross-over, single center study of patients with diabetes mellitus type 1 without chronic complications.

Dipeptidyl-peptidase-4

STEMI

No-reflow

Bleeding

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

TIMI flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow

the composite of death, nonfatal MI, or stroke

defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia

defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event

Li Jing Wei

Chinese PLA General Hospital

Best available therapy, as chosen by the investigator for patients who had been on HU in the 1 Year PROUD-PV study

AOP2014 for those patients who had been on AOP2014 in the PROUD-PV study

Polycythemia Vera

Subjects will continue to receive the dosage which delivers the optimal disease response (hematocrit [Hct]<45%, platelets [PLTs]<400 x 109/L and leukocytes [WBCs]<10 x 109/L), as determined in the PROUD-PV study, preferably at the level of target blood values.

Pegylated-Proline-interferon alpha-2b

Best available therapy as selected by the investigator

Best available therapy (BAT)

LKH Graz

University Hospital Innsbruck

Elisabethinen Hospital Linz

Salzburg Regional Hospital

Hanusch Hospital

Medical University Vienna

Hospital Wels-Grieskirchen

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

Specialized Hospital for Active Treatment of Hematological Diseases

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine

University Hospital Brno

University Hospital Hradec Kralove

University Hospital Kralovske Vinohrady

University Hospital Motol

Institute Paoli-Calmettes

Hospital Saint-Louis

Clinical Research Center CIC

Aachen University Hospital, Medical Clinic IV

University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III

University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I

St Istvan and St Laszlo Hospital of Budapest

University of Debrecen

Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology

Kaposi Mor County Teaching Hospital

University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6

University Hospital in Cracow

Independent Public Teaching Hospital No.1 in Lublin

Fryderyk Chopin Provincial Specialized Hospital

Nicolaus Copernicus Municipal Specialist Hospital

Institute of Hematology and Transfusion Medicine

Emergency Clinical County Hospital Brasov

Bucharest University Emergency Hospital

Coltea Clinical Hospital

Baranov Republican Hospital

Samara Kalinin Regional Clinical Hospital

Komi Republican Oncology Center

Tula Regional Clinical Hospital

Yaroslavl Regional Clinical Hospital

University Hospital with Outpatient Clinic F.D. Roosevelt

Saint Cyril and Metod University Hospital Bratislava

Hospital del Mar

Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center

Dnipropetrovsk City Multispecialty Clinical Hospital #4

National Research Center for Radiation Medicine, Institute of Clinical Radiology

Institute of Blood Pathology and Transfusion Medicine

O.F. Herbachevskyi Regional Clinical Hospital

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

An Open-label, Multicenter, Phase IIIb Study Assessing the Long-term Efficacy and Safety of AOP2014 and Standard First Line Treatment (BAT) in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study

The primary efficacy endpoint will be the rate of disease response at assessment visits (every 3 months).
The co-primary efficacy evaluation criterion will be (1) disease response defined as hematologic response: Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size, and (2) disease response defined as hematologic response (Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L), resolution and/or clinically improvement of disease-related signs (clinical significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).

AOP Orphan Pharmaceuticals AG

PharmaEssentia (Co-Sponsor for USA)

infarction

proline

infarction/proline

Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

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