Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02171156
• Date of registration: 18/06/2014
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)
• Scientific title: Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: May 2014
• Recruitment status: Approved for marketing
• URL: https://clinicaltrials.gov/show/NCT02171156
• Study type: Expanded Access
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

1. Signed Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the trial;

2. Male or female patients aged >=40 years at Visit 1;

3. 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;

4. Carbon monoxide diffusing capacity (DLCO)(corrected for Haemoglobin (Hb)): 30%-79%
predicted of normal, per institutional standards at the clinic site, at Visit 1;

5. Forced Vital Capacity (FVC) >= 50% predicted of normal, per institutional standards at
the clinic site, at Visit 1.

Exclusion criteria:

1. 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).

2. ALT, AST > 1.5 times upper limit of normal (ULN);

3. Total Bilirubin > 1.5 times upper limit of normal (ULN);

4. Bleeding risk:

1. 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);

2. history of hemorrhagic central nervous system (CNS) event within 12 months of
Visit 1;

3. any of the following within 3 months of Visit 1;

- hemoptysis or haematuria

- active gastro-intestinal bleeding or ulcers

- major injury or surgery

4. coagulation parameters:

- international normalised ratio (INR) > 2

- prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of
institutional upper limit of normal (ULN)

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

6. Thrombotic risk:

1. known inherited predisposition to thrombosis

2. history of thrombotic event (including stroke and transient ischemic attacks)
within 12 months of Visit 1;

7. Cardiac disease:

1. Myocardial infarction within 6 months of Visit 1

2. Unstable angina within 1 month of Visit 1;

8. Current or planned usage (during the course of this trial) of any other
investigational drug during the course of this trial;

9. 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);

10. Permanent discontinuation of nintedanib within a clinical trial, due to adverse events
considered drug-related;

11. Known hypersensitivity to nintedanib or its excipients;

12. 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;

13. Alcohol or drug abuse which in the opinion of the treating physician would interfere
with participation;

14. Women (of child-bearing potential) who are unwilling to use acceptable methods of
contraception;

15. Pregnancy or breast feeding (female patients must have a negative pregnancy test
(ß-HCG test in urine or serum) prior to commencing trial treatment).



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: nintedanib

Secondary ID(s)

1199.177

Source(s) of Monetary Support

Please refer to primary and secondary sponsors