Back to resultsRoll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Pulmonary Fibrosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIBF 1120
BIBF 1120
BIBF 1120
BIBF 1120
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Fibrosis
Eligibility Criteria
Inclusion criteria:
- Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
- Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
- Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Exclusion criteria:
- Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
- Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
- Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
- Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
- Known or suspected active alcohol or drug abuse.
- Patient not compliant in previous trial, with trial medication or trial visits.
Sites / Locations
- INSARES
- Respiratory Clinical Trial Pty Ltd.
- The Queen Elizabeth Hospital
- Royal Perth Hospital-Lung Transplant Unit
- ULB Hopital Erasme
- UZ Leuven
- Yvoir - UNIV UCL de Mont-Godinne
- Irmandade Santa Casa de Misericordia de Porto Alegre
- Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
- QEII Health Sciences Centre (Dalhousie University)
- St. Joseph's Healthcare Hamilton
- Instituto Nacional del Tórax
- Beijing Chao-Yang Hospital
- Peking Union Medical College Hospital
- Nanjing Drum Tower Hospital
- Shanghai Pulmonary Hospital
- University Hospital Na Bulovce, Prague
- Masaryk Hospital, Usti nad Labem
- HOP Avicenne
- HOP Dijon, Pneumo, Dijon
- HOP Calmette
- HOP Calmette
- HOP Arnaud de Villeneuve
- HOP Pasteur
- HOP Bichat
- Klinik Donaustauf
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- Universitätsklinikum Freiburg
- Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Klinikum der Universität München - Campus Großhadern
- University General Hospital of Evros
- University Hospital of Heraklion, University Pulmonology Cl
- Csongrad County's Hosp.
- University of Pecs, 1st internal Med. Dept., Pulmonology
- Mater Misericordiae University Hospital
- Ospedale C. G. Mazzoni
- Osp. S. Giuseppe Fatebenefratelli
- Università di Modena e Reggio Emilia
- Università Federico II
- Pol. Universitario Tor Vergata
- A.O.U. Senese Policlinico Santa Maria alle Scotte
- Università di Perugia
- Ospedale di Cattinara
- Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
- St. Antonius ziekenhuis, locatie Nieuwegein
- CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
- CHLN, EPE - Hospital de Santa Maria
- Centro Hospitalar Lisboa Norte Hospital Pulido Valente
- Centro Hospitalar São João,EPE
- Central Scientific Research Insitute of Tuberculosis
- Scientific Research Institute of Pulmonology
- Hospital Vall d'Hebron
- Hospital Dr. Peset
- Queen Elizabeth Hospital
- Birmingham Heartlands Hospital
- The Medicines Evaluation Unit
- Southmead Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
BIBF 1120 low qd
BIBF 1120 low bid
BIBF 1120 medium bid
BIBF 1120 high bid
Arm Description
Low dose BIBF 1120 once daily
Low dose BIBF 1120 twice daily
Intermediate dose BIBF 1120 twice daily
High dose BIBF 1120 twice daily
Outcomes
Primary Outcome Measures
Annual Rate of Decline in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
For this endpoint reported means represent the adjusted rate.
Secondary Outcome Measures
Overall Survival
Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.
For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
Progression-Free Survival
Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.
For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.
Haemoglobin corrected DLCO was calculated for each patient using the following formulae:
Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.
An exacerbation was defined as otherwise unexplained clinical features occurring within
1 month including all of the following:
Progression of dyspnoea over several days to 4 weeks
New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit
Exclusion of infection based on routine clinical practice and microbiological studies
Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time to First Acute IPF Exacerbation
Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs
Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01170065
Brief Title
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2010 (Actual)
Primary Completion Date
September 26, 2016 (Actual)
Study Completion Date
September 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).
As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIBF 1120 low qd
Arm Type
Experimental
Arm Description
Low dose BIBF 1120 once daily
Arm Title
BIBF 1120 low bid
Arm Type
Experimental
Arm Description
Low dose BIBF 1120 twice daily
Arm Title
BIBF 1120 medium bid
Arm Type
Experimental
Arm Description
Intermediate dose BIBF 1120 twice daily
Arm Title
BIBF 1120 high bid
Arm Type
Experimental
Arm Description
High dose BIBF 1120 twice daily
Intervention Type
Drug
Intervention Name(s)
BIBF 1120
Intervention Description
Intermediate dose BIBF 1120 twice daily
Intervention Type
Drug
Intervention Name(s)
BIBF 1120
Intervention Description
High dose BIBF 1120 twice daily
Intervention Type
Drug
Intervention Name(s)
BIBF 1120
Intervention Description
Low dose BIBF 1120 twice daily
Intervention Type
Drug
Intervention Name(s)
BIBF 1120
Intervention Description
Low dose BIBF 1120 once daily
Primary Outcome Measure Information:
Title
Annual Rate of Decline in Forced Vital Capacity (FVC)
Description
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
For this endpoint reported means represent the adjusted rate.
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.
For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Title
Progression-Free Survival
Description
Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.
For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
Time Frame
From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
Title
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Description
Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.
Haemoglobin corrected DLCO was calculated for each patient using the following formulae:
Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Title
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Description
Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.
An exacerbation was defined as otherwise unexplained clinical features occurring within
1 month including all of the following:
Progression of dyspnoea over several days to 4 weeks
New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit
Exclusion of infection based on routine clinical practice and microbiological studies
Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Title
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Description
Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Title
Time to First Acute IPF Exacerbation
Description
Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
Time Frame
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Title
Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs
Description
Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Time Frame
From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Exclusion criteria:
Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
Known or suspected active alcohol or drug abuse.
Patient not compliant in previous trial, with trial medication or trial visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
INSARES
City
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Respiratory Clinical Trial Pty Ltd.
City
Glen Osmond
State/Province
South Australia
ZIP/Postal Code
5064
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Perth Hospital-Lung Transplant Unit
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Yvoir - UNIV UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
CEP90035-0
Country
Brazil
Facility Name
Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
QEII Health Sciences Centre (Dalhousie University)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Instituto Nacional del Tórax
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
University Hospital Na Bulovce, Prague
City
Prague 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Masaryk Hospital, Usti nad Labem
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
HOP Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
HOP Dijon, Pneumo, Dijon
City
DIJON Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
HOP Calmette
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
HOP Pasteur
City
Nice Cedex 1
ZIP/Postal Code
06002
Country
France
Facility Name
HOP Bichat
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Klinik Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg/Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum der Universität München - Campus Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
University General Hospital of Evros
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
University Hospital of Heraklion, University Pulmonology Cl
City
Heraklion
ZIP/Postal Code
71100
Country
Greece
Facility Name
Csongrad County's Hosp.
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
University of Pecs, 1st internal Med. Dept., Pulmonology
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Ospedale C. G. Mazzoni
City
Ascoli Piceno
ZIP/Postal Code
63100
Country
Italy
Facility Name
Osp. S. Giuseppe Fatebenefratelli
City
Milano
ZIP/Postal Code
20123
Country
Italy
Facility Name
Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Università Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pol. Universitario Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Università di Perugia
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale di Cattinara
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Facility Name
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
City
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
St. Antonius ziekenhuis, locatie Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
CHLN, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1064-035
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1750-001 L
Country
Portugal
Facility Name
Centro Hospitalar São João,EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Central Scientific Research Insitute of Tuberculosis
City
Moscow
ZIP/Postal Code
107564
Country
Russian Federation
Facility Name
Scientific Research Institute of Pulmonology
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
The Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Southmead Hospital
City
Westbury On Trym
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28993537
Citation
Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
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