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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01335477




Registration number
NCT01335477
Ethics application status
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
25/07/2016

Titles & IDs
Public title
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
Scientific title
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2010-024252-29
Secondary ID [2] 0 0
1199.34
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - BIBF 1120

Placebo Comparator: placebo - patient receives capsules identical to those containing active drug

Experimental: BIBF 1120 - patient receives capsules containing BIBF 1120 twice a day


Treatment: Drugs: placebo
placebo matching BIBF 1120 BID

Treatment: Drugs: BIBF 1120
BIBF 1120 BID (twice daily)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks
Timepoint [1] 0 0
Baseline and 52 weeks
Secondary outcome [2] 0 0
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [3] 0 0
Baseline and 52 weeks
Secondary outcome [4] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks
Timepoint [4] 0 0
Baseline and 52 weeks
Secondary outcome [5] 0 0
Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [5] 0 0
Baseline and 52 weeks
Secondary outcome [6] 0 0
Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks
Timepoint [6] 0 0
Baseline and 52 weeks
Secondary outcome [7] 0 0
Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold
Timepoint [7] 0 0
Baseline and 52 weeks
Secondary outcome [8] 0 0
Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold
Timepoint [8] 0 0
Baseline and 52 weeks
Secondary outcome [9] 0 0
FVC Responders Using 10% Threshold at 52 Weeks
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
Proportion of FVC Responders Using 5% Threshold at 52 Weeks
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [11] 0 0
baseline and 52 weeks
Secondary outcome [12] 0 0
Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [12] 0 0
baseline and 52 weeks
Secondary outcome [13] 0 0
Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [13] 0 0
baseline and 52 weeks
Secondary outcome [14] 0 0
Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [14] 0 0
baseline and 52 weeks
Secondary outcome [15] 0 0
Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)
Timepoint [15] 0 0
baseline and 52 weeks
Secondary outcome [16] 0 0
Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [16] 0 0
baseline and 52 weeks
Secondary outcome [17] 0 0
Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [17] 0 0
baseline and 52 weeks
Secondary outcome [18] 0 0
Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [18] 0 0
baseline and 52 weeks
Secondary outcome [19] 0 0
Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)
Timepoint [19] 0 0
52 weeks
Secondary outcome [20] 0 0
Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)
Timepoint [20] 0 0
baseline, 12 weeks, 24 weeks and 52 weeks
Secondary outcome [21] 0 0
Risk of an Acute IPF Exacerbation Over 52 Weeks
Timepoint [21] 0 0
52 weeks
Secondary outcome [22] 0 0
Time to Death Over 52 Weeks
Timepoint [22] 0 0
52 weeks
Secondary outcome [23] 0 0
Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)
Timepoint [23] 0 0
52 weeks
Secondary outcome [24] 0 0
Time to On-treatment Death
Timepoint [24] 0 0
52 weeks
Secondary outcome [25] 0 0
Time to Death or Lung Transplant Over 52 Weeks
Timepoint [25] 0 0
52 weeks
Secondary outcome [26] 0 0
Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.
Timepoint [26] 0 0
52 weeks
Secondary outcome [27] 0 0
Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks
Timepoint [27] 0 0
baseline and 52 weeks
Secondary outcome [28] 0 0
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks
Timepoint [28] 0 0
baseline and 52 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Age >= 40 years;

2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
Association (ALAT) IPF guideline for diagnosis and management, within 5 years;

3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
available surgical lung biopsy pattern, as assessed by central reviewers, are
consistent with diagnosis of IPF

4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC>= 50% predicted of normal
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
of Normal (ULN)

2. Bilirubin > 1.5 x ULN;

3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);

4. Patient likely to have lung transplantation during study (being on transplantation
list is acceptable for participation);

5. Myocardial infarction within 6 months;

6. Unstable angina within 1 month;

7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
ulcers or major injury or surgery within 3 months);

8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
stroke and transient ischemic attacks) within 12 months;

9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by > 50% of institutional ULN);

10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
1;

11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
visit 1;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in
scarring of the lung and there is a high unmet medical need for effective treatment to halt
lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the
death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of
treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of
patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of
BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will
be conducted as a prospective, randomised design with the aim to collect safety and efficacy
data.

Respiratory function is globally accepted for assessment of treatment effects in IPF
patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is
part of the usual examinations done in IPF patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01335477
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries