1199.35 A roll-over study of oral BIBF 1120 in patients with IPF

• Research type

  Research Study

• Full title

  A phase II open label, roll-over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)

• IRAS ID

  49891

• Contact name

  David Thickett

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2009-013788-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is no drug that is licensed for this disease and no treatment strategies that have been proven to reduce the death rate. Hence it is the purpose of this trial to offer the option to all patients who completed a randomized BIBF 1120 trial (trial No. 1199.30) in the indication IPF, to continue BIBF 1120 treatment if they perceive an individual benefit. The decision to continue treatment will be taken by the patient following discussion with the investigator. The aim of the study is to allow treatment continuation to individual patients. The trial will be conducted as a prospective, open-label design with the aim to collect safety and efficacy data. The observation period for this study will extend until either every patient is discontinued or a reason for stopping the trial is met. Respiratory function is the gold standard for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity decline) is easy to obtain and is part of the usual examinations done in IPF patients. As with the original study it is thought to be an appropriate endpoint for such a rollover study.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/30

• Date of REC Opinion

  13 May 2010

• REC opinion

  Further Information Favourable Opinion