drugset / Trial / NCT01417156
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
NaSingle-groupOpen-labelTreatment
Summary
Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31). Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.
Timeline
- Start
- 2011-09
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 150 mg | Oral |
| Background | Pirfenidone | Small molecule | — | — |