Idiopathic Pulmonary FibrosisNCT02230982
Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis
A study testing nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 8 sites in Brazil.
Trial summary
To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- nintedanib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 8 sitesBrazil
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the trial;
- Male or female patients aged >=40 years at Visit 1;
- IPF diagnosis based upon the American Thoracic Society (ATS)/European Respiratory Society (ERS) /Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) IPF 2011 guideline within 5 years of visit 1;
- Carbon monoxide diffusing capacity (DLCO) (corrected for Haemoglobin (Hb)): 30%-79% predicted of normal, per institutional standards at the clinic site, at Visit 1;
- Forced Vital Capacity (FVC) >= 50% predicted of normal, per institutional standards at the clinic site, at Visit 1.
Who cannot join
- Eligible to participate or participating in an ongoing actively accruing clinical trial with nintedanib in the treatment of IPF.
- Laboratory parameters from Visit 1 must satisfy entry criteria as shown below. Abnormal laboratory parameters may be re-tested if a measurement error is suspected (e.g., there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign). The results of the re-test should be reported within the Screening period (i.e., 28 days of signing the informed consent form).
- ALT, AST > 1.5 times upper limit of normal (ULN);
- Total Bilirubin > 1.5 times upper limit of normal (ULN);
- Bleeding risk:
- patients who require: fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.), or high-dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g., enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g., acetylsalicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy);
Show all 29Show fewer
- history of hemorrhagic central nervous system (CNS) event within 12 months of Visit 1;
- any of the following within 3 months of Visit 1;
- hemoptysis or haematuria
- active gastro-intestinal bleeding or ulcers
- major injury or surgery
- coagulation parameters:
- international normalised ratio (INR) > 2
- prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional upper limit of normal (ULN)
- Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery;
- Thrombotic risk:
- known inherited predisposition to thrombosis
- history of thrombotic event (including stroke and transient ischemic attacks) within 12 months of Visit 1;
- Cardiac disease:
- Myocardial infarction within 6 months of Visit 1
- Unstable angina within 1 month of Visit 1;
- Current or planned usage (during the course of this trial) of any other investigational drug during the course of this trial;
- Current or planned treatment (during the course of this trial) with: pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone >15 mg daily or > 30 mg every 2 days OR equivalent dose of other oral corticosteroids, as well as those listed in exclusion criteria #4 (bleeding risk);
- Permanent discontinuation of nintedanib within a clinical trial, due to adverse events considered drug-related;
- Known hypersensitivity to nintedanib or its excipients;
- A disease or condition which in the opinion of treating physician may put the patient at risk because of participation in this trial or limit the patient's ability to participate in this trial;
- Alcohol or drug abuse which in the opinion of the treating physician would interfere with participation;
- Women (of child-bearing potential) who are unwilling to use acceptable methods of contraception;
- Pregnancy or breast feeding (female patients must have a negative pregnancy test (ß-HCG test in urine or serum) prior to commencing trial treatment).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Centro Medico Santa Maria
Barra Mansa, 27323240
CLARE - Clinica de Pneumologia
Goiânia, 74110-030
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074
H.C.da Fac. de Medicina de Ribeirao Preto
Ribeirão Preto, 14048-900
Universidade do Estado do Rio de Janeiro
Rio de Janerio, 20950-000
Hospital Ana Nery
Salvador, 40323010
Hospital das Clínicas de Sao Paulo - INCOR
São Paulo, 05403-000
UNIFESP Departamento de Medicina de Pneumologia
Sao Paulo - SP, 04023900
About this study
Official title: Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis
To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- nintedanib
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nintedanibDrug
soft gelatin capsule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Expanded access
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
- NCT02230982
- Sponsor's protocol ID
- 1199.192
- Status last verified
- Feb 2019
- First submitted
- 29 Aug 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02230982
- Acronym / sponsor ID
- 1199.192
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF)
Study design
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the trial;
- Male or female patients aged >=40 years at Visit 1;
- IPF diagnosis based upon the American Thoracic Society (ATS)/European Respiratory Society (ERS) /Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) IPF 2011 guideline within 5 years of visit 1;
- Carbon monoxide diffusing capacity (DLCO) (corrected for Haemoglobin (Hb)): 30%-79% predicted of normal, per institutional standards at the clinic site, at Visit 1;
- Forced Vital Capacity (FVC) >= 50% predicted of normal, per institutional standards at the clinic site, at Visit 1.
Key exclusion criteria (29 listed)
- Eligible to participate or participating in an ongoing actively accruing clinical trial with nintedanib in the treatment of IPF.
- Laboratory parameters from Visit 1 must satisfy entry criteria as shown below. Abnormal laboratory parameters may be re-tested if a measurement error is suspected (e.g., there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign). The results of the re-test should be reported within the Screening period (i.e., 28 days of signing the informed consent form).
- ALT, AST > 1.5 times upper limit of normal (ULN);
- Total Bilirubin > 1.5 times upper limit of normal (ULN);
- Bleeding risk:
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 |
|---|---|---|
| nintedanibsoft gelatin capsule | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 8 sites in Brazil.
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 5 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 8 Feb 2019.