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

NCT02171156 | Unknown

• 1 other identifier: 1199.177
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

To provide early access and to evaluate the safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib DRUG

soft gelatin capsule

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

1199.177.1003 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1199.177.1012 Boehringer Ingelheim Investigational Site

Skokie, Illinois, United States

Location

1199.177.1014 Boehringer Ingelheim Investigational Site

Muncie, Indiana, United States

Location

1199.177.1002 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

1199.177.1011 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1199.177.1022 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1199.177.1067 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 24, 2014
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (7)