Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis

NCT02230982 | Unknown

• 1 other identifier: 1199.192
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 8

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 (8)

Centro Medico Santa Maria

Barra Mansa, 27323240, Brazil

Location

CLARE - Clinica de Pneumologia

Goiânia, 74110-030, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

H.C.da Fac. de Medicina de Ribeirao Preto

Ribeirão Preto, 14048-900, Brazil

Location

Universidade do Estado do Rio de Janeiro

Rio de Janerio, 20950-000, Brazil

Location

Hospital Ana Nery

Salvador, 40323010, Brazil

Location

UNIFESP Departamento de Medicina de Pneumologia

Sao Paulo - SP, 04023900, Brazil

Location

Hospital das Clínicas de Sao Paulo - INCOR

São Paulo, 05403-000, Brazil

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: August 29, 2014
• First Posted: September 3, 2014
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

BR (8)