A Follow-up Study of Long Term Treatment With Experimental Nintedanib For Progressive Fibrosing Interstitial Lung Disease

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: lung diseases, interstitial lung disease, ILD, Progressive Fibrosing Interstitial Lung Disease, Fibrosing Interstitial Lung Disease, extension study
Type: Drug study, Phase 3
Target:
3 Participants
Investigator:
Description
This study is being done to find out how safe it is for patients to take experimental nintedanib long-term. We hope to learn how well it is tolerated (accepted) in patients who completed the INBUILD® study. Nintedanib has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for PF-ILD. Nintedanib is experimental for this study. It has been approved by the FDA to treat idiopathic pulmonary fibrosis.

This study is for research purposes only and will help to gain information for providing better or new treatments for people in the future. This is different from regular medical care, where the purpose is to help each individual person.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion criteria:

  • Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • Previous enrolment in this trial.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will be paid for the study visits you complete according to the following schedule:
-$50.00 each for visits 1, 5A, 7A, and F/U
-$100.00 each for visits 2, 4
-$200.00 each for visits 3, 5, 6, 7, 8, visits X and EOT.
You will receive $25.00 for each phone visit you complete instead of a study center visit. If you do not complete this study, for any reason, you will be paid for the study visits you do complete. If you come to the study center for any unscheduled visits, you will be paid $50.00 for each additional visit.
Resources
Schedule
Study duration and period
You will be in this study for about 2 years and have about 12 visits. Your participation in this study will last longer and you will have more visits if nintedanib is not available by prescription. During the first year, you will have about 8 visits to the study center. After visit 8, you will only have to come to the study center every 12 weeks until you can receive nintedanib by prescription.
Recruitment period
From May 6, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Lung Diseases
  • Interstitial