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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/NCT01619085




Registration number
NCT01619085
Ethics application status
Date submitted
6/06/2012
Date registered
14/06/2012
Date last updated
25/03/2022

Titles & IDs
Public title
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Scientific title
An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2011-002766-21
Secondary ID [2] 0 0
1199.33
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic 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 - Nintedanib

Experimental: All subjects - patient to receive a capsule containing Nintedanib twice a day


Treatment: Drugs: Nintedanib
Nintedanib twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed Informed Consent consistent with International Conference on Harmonisation-Good
Clinical Practices (ICH-GCP) and local laws prior to trial participation.

2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
and performed the follow-up visit.
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 fold Upper
Limit of Normal (ULN) (Patients who completed the parent trial with transaminase
values > 1.5 fold ULN but < 3 fold ULN are considered eligible)

2. Bilirubin > 1.5 fold ULN

3. Bleeding risk

4. Planned major surgery within the next 3 months, including lung transplantation, major
abdominal or major intestinal surgery.

5. New major thrombo-embolic events developed after completion of the parent trial.

6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.

7. Usage of any investigational drug after completion of the parent trial or planned
usage of a specific investigational drug during the course of this trial.

8. A disease or condition which in the opinion of investigator may put the patient at
risk because of participation in this trial or limit the patients' ability to
participate in this trial.

9. Alcohol or drug abuse which in the opinion of the investigator would interfere with
trial participation.

10. Pregnant women or women who are breast feeding or of child bearing potential not using
two effective methods of birth control (one barrier and one highly effective
non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it
until 3 months after end of treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
6/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
Accrual to date
Final
752
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Frankston Hospital - Frankston
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2137 - Concord
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
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L´Hospitalet de Llobregat
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Izmir
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Aberdeen
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Birmingham
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Oxford
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Westbury On Trym

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in
patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the
follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and
1199.34), who wish to continue treatment with BIBF 1120.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01619085
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01619085