Pulmonary FibrosisPhase 2NCT01170065
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing BIBF 1120 in people with Pulmonary Fibrosis, run by Boehringer Ingelheim at 57 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- BIBF 1120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 57 sitesin 21 countries
- Study dates
- 25 Jun 2010to 26 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
57 sites in 21 countries.
57 sites in 21 countries
Italy8 sites
Ospedale C. G. Mazzoni
Ascoli Piceno, 63100
Osp. S. Giuseppe Fatebenefratelli
Milan, 20123
Università di Modena e Reggio Emilia
Modena, 41100
Università Federico II
Naples, 80131
Pol. Universitario Tor Vergata
Roma, 00133
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100
Università di Perugia
Terni, 05100
Ospedale di Cattinara
Trieste, 34100
France6 sites
HOP Avicenne
Bobigny, 93009
HOP Dijon, Pneumo, Dijon
Dijon, 21079
HOP Calmette
Lille, 59037
HOP Arnaud de Villeneuve
Montpellier, 34295
HOP Pasteur
Nice, 06002
HOP Bichat
Paris, 75877
Germany6 sites
Klinik Donaustauf
Donaustauf, 93093
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Universitätsklinikum Freiburg
Freiburg/Breisgau, 79106
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Klinikum der Universität München - Campus Großhadern
München, 81377
China4 sites
Beijing Chao-Yang Hospital
Beijing, 100020
Peking Union Medical College Hospital
Beijing, 100730
Nanjing Drum Tower Hospital
Nanjing, 210008
Shanghai Pulmonary Hospital
Shanghai, 200433
Portugal4 sites
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3041-801
CHLN, EPE - Hospital de Santa Maria
Lisbon, 1064-035
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, 1750-001 L
Centro Hospitalar São João,EPE
Porto, 4202-451
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2GW
Birmingham Heartlands Hospital
Birmingham, B9 5SS
The Medicines Evaluation Unit
Manchester, M23 9QZ
Southmead Hospital
Westbury on Trym, BS10 5NB
Australia3 sites
Respiratory Clinical Trial Pty Ltd.
Glen Osmond, South Australia, 5064
Royal Perth Hospital-Lung Transplant Unit
Perth, Western Australia, 6000
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Belgium3 sites
ULB Hopital Erasme
Brussels, 1070
UZ Leuven
Leuven, 3000
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530
Canada2 sites
QEII Health Sciences Centre (Dalhousie University)
Halifax, Nova Scotia, B3H 3A7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Czechia2 sites
University Hospital Na Bulovce, Prague
Prague, 180 81
Masaryk Hospital, Usti nad Labem
Ústí nad Labem, 401 13
Greece2 sites
University General Hospital of Evros
Alexandroupoli, 68100
University Hospital of Heraklion, University Pulmonology Cl
Heraklion, 71100
Hungary2 sites
Csongrad County's Hosp.
Deszk, 6772
University of Pecs, 1st internal Med. Dept., Pulmonology
Pécs, 7623
Russia2 sites
Central Scientific Research Insitute of Tuberculosis
Moscow, 107564
Scientific Research Institute of Pulmonology
Saint Petersburg, 197089
Spain2 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Dr. Peset
Valencia, 46017
Brazil1 site
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, CEP90035-0
Bulgaria1 site
Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
Sofia, 1431
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Distrito Federal, 14080
Netherlands1 site
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM
About this study
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
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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- BIBF 1120
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
Intermediate dose BIBF 1120 twice daily
BIBF 1120Drug
High dose BIBF 1120 twice daily
BIBF 1120Drug
Low dose BIBF 1120 twice daily
BIBF 1120Drug
Low dose BIBF 1120 once daily
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 low qd | Experimental | Low dose BIBF 1120 once daily Receives: Drug: BIBF 1120 |
| BIBF 1120 low bid | Experimental | Low dose BIBF 1120 twice daily Receives: Drug: BIBF 1120 |
| BIBF 1120 medium bid | Experimental | Intermediate dose BIBF 1120 twice daily Receives: Drug: BIBF 1120 |
| BIBF 1120 high bid | Experimental | High dose BIBF 1120 twice daily Receives: Drug: BIBF 1120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcomes (7)
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.
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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.
Measured: From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
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.
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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.
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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.
Measured: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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
Measured: From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study start25 Jun 2010
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170065
- Sponsor's protocol ID
- 1199.35
- Other IDs
- 2009-013788-21, 2009
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2010
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 28993537
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01170065
- Acronym / sponsor ID
- 1199.35
- Conditions
- Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2010 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 low qd | Experimental | Drug: BIBF 1120Low dose BIBF 1120 once daily |
| BIBF 1120 low bid | Experimental | Drug: BIBF 1120Low dose BIBF 1120 twice daily |
| BIBF 1120 medium bid | Experimental | Drug: BIBF 1120Intermediate dose BIBF 1120 twice daily |
| BIBF 1120 high bid | Experimental | Drug: BIBF 1120High dose BIBF 1120 twice daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF 1120Intermediate dose BIBF 1120 twice daily | Drug | BIBF 1120 medium bid |
| BIBF 1120High dose BIBF 1120 twice daily | Drug | BIBF 1120 high bid |
| BIBF 1120Low dose BIBF 1120 twice daily | Drug | BIBF 1120 low bid |
| BIBF 1120Low dose BIBF 1120 once daily | Drug | BIBF 1120 low qd |
Primary outcome
Annual Rate of Decline in Forced Vital Capacity (FVC)
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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.
7 secondary outcomes
Overall Survival
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Progression-Free Survival
Time frame: From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Time to First Acute IPF Exacerbation
Time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28993537Richeldi 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
57 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBF 1120 in people with Pulmonary Fibrosis, run by Boehringer Ingelheim at 57 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Italy, France, Germany, China, Portugal and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Rate of Decline in Forced Vital Capacity (FVC) (time frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.