NCT02707640 - A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF) | Biotech Hunter

Enrollment

123

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

DRUG

Matching Placebo

Matching Placebo, oral administration, three times daily for 24 weeks.

DRUG

N-acetylcysteine

N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.

DRUG

Pirfenidone

Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.

Trial Locations (69)

1070

Brussels

2900

Hellerup

3000

Leuven

5000

Odense C

5020

Salzburg

5530

Mont-godinne

6020

Innsbruck

8000

Aarhus

8036

Graz

10043

Orbassano

10117

Berlin

13125

Berlin

13915

Marseille

14165

Berlin

17176

Stokholm, Solna

17475

Greifswald

20142

Milan

20900

Monza

29609

Brest

31059

Toulouse

34129

Trieste

34149

Cattinara Trieste

34295

Montpellier

34376

Immenhausen

35033

Rennes

35037

Marburg

35392

Giessen

37044

Tours

39120

Magdeburg

42699

Solingen

44789

Bochum

45239

Essen

51092

Reims

53100

Siena

53127

Bonn

56124

Pisa

59037

Lille

69126

Heidelberg

69677

Bron

75877

Paris

79182

Falun

80131

Napoli

81377

München

93000

Bobigny

93093

Donaustauf

99437

Bad Berka

Unknown

Dijon

Bamberg

Freiburg im Breisgau

Hamburg

Münnerstadt

Würzburg

Catania

Padua

London

Oxford

Sheffield

01640

Coswig

00133

Rome

221 85

Lund

751 85

Uppsala

BS10-5NB

Bristol

CB23 3RE

Cambridge

EX2 5DW

Exeter

LS9 7TF

Leeds

L9 7AL

Liverpool

NW1 2BU

London

SW3 6NP

London

SO16 6YD

Southampton

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY