Conditions: Pulmonary Fibrosis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 198
Healthy volunteers: no

Brief summary:
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.

Detailed description:

Arms:
arm 1: Low dose BIBF 1120 once daily arm 2: Low dose BIBF 1120 twice daily arm 3: Intermediate dose BIBF 1120 twice daily arm 4: High dose BIBF 1120 twice daily

Interventions: intervention 1: BIBF 1120 intervention 2: BIBF 1120 intervention 3: BIBF 1120 intervention 4: BIBF 1120
Intervention descriptions: intervention 1: Intermediate dose BIBF 1120 twice daily intervention 2: High dose BIBF 1120 twice daily intervention 3: Low dose BIBF 1120 twice daily intervention 4: Low dose BIBF 1120 once daily

Protocol document: