Clinical Trials

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)* 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
  • *A woman is considered of childbearing potential (WOCBP); i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation.  A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

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.
• Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.