NCT02038036 - Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. | Biotech Hunter

Enrollment

149

Participants

Timeline

Start Date

March 25, 2014

Primary Completion Date

September 29, 2015

Study Completion Date

April 7, 2020

Conditions

Polycythemia Vera

Interventions

DRUG

Best Available Therapy

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.

DRUG

Ruxolitinib

Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.

Trial Locations (48)

1085

Novartis Investigative Site, Budapest

2060

Novartis Investigative Site, Antwerp

3000

Novartis Investigative Site, Leuven

4029

Novartis Investigative Site, Herston

4032

Novartis Investigative Site, Debrecen

7400

Novartis Investigative Site, Kaposvár

10126

Novartis Investigative Site, Torino

15006

Novartis Investigative Site, A Coruña

20122

Novartis Investigative Site, Milan

21100

Novartis Investigative Site, Varese

22100

Novartis Investigative Site, Nahariya

27100

Novartis Investigative Site, Pavia

28034

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

29200

Novartis Investigative Site, Brest

31008

Novartis Investigative Site, Pamplona

31059

Novartis Investigative Site, Toulouse

32429

Novartis Investigative Site, Minden

33076

Novartis Investigative Site, Bordeaux

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

35040

Novartis Investigative Site, Izmir

37007

Novartis Investigative Site, Salamanca

38039

Novartis Investigative Site, Talas / Kayseri

39120

Novartis Investigative Site, Magdeburg

40138

Novartis Investigative Site, Bologna

42150

Novartis Investigative Site, Netanya

50134

Novartis Investigative Site, Florence

55131

Novartis Investigative Site, Mainz

59020

Novartis Investigative Site, Lille

64109

Novartis Investigative Site, Bayonne

68305

Novartis Investigative Site, Mannheim

75010

Novartis Investigative Site, Paris

86150

Novartis Investigative Site, Augsburg

89081

Novartis Investigative Site, Ulm

400012

Novartis Investigative Site, Mumbai

6423906

Novartis Investigative Site, Tel Aviv

M4N 3M5

Novartis Investigative Site, Toronto

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

632 004

Novartis Investigative Site, Vellore

00168

Novartis Investigative Site, Rome

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

03010

Novartis Investigative Site, Alicante