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Clinical Trial Results:
An open-label extension trial of the long-term safety of oral BIBF 1120 in patients with idiopathic pulmonary fibrosis (IPF)

Summary
EudraCT number	2011-002766-21
Trial protocol	GR PT BE ES DE FI GB CZ IT IE
Global end of trial date	01 Feb 2021

Results information
Results version number	v2(current)
This version publication date	16 Mar 2022
First version publication date	05 Feb 2022
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

1199.33

ISRCTN number

US NCT number

NCT01619085

WHO universal trial number (UTN)

Sponsor organisation name

Boehringer Ingelheim

Sponsor organisation address

Binger Strasse 173, Ingelheim am Rhein, Germany, 55216

Public contact

Boehringer Ingelheim Call Center, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com

Scientific contact

Boehringer Ingelheim, Call Center, Boehringer Ingelheim, +1 18002430127, clintriage.rdg@boehringer-ingelheim.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

22 Feb 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Jul 2017

Global end of trial reached?

Yes

Global end of trial date

01 Feb 2021

Was the trial ended prematurely?

Main objective of the trial

The primary objective of the trial was to assess the long-term safety of oral nintedanib treatment in patients with IPF who had completed 52 weeks of treatment and the follow-up period of Phase III parent trial 1199.32 or 1199.34.

Protection of trial subjects

All patients were informed that they were free to withdraw their consent at any time during the trial without penalty and prejudice. The signed informed consent forms and any additional patient information were retained by the investigator as part of the trial records. Each patient received a copy of the signed informed consent form and any additional patient information. Patients were informed that their medical records could be examined by authorised monitors or Clinical Quality Assurance auditors of BI, members of the appropriate IEC/IRB, and regulatory authority inspectors. Patients were also informed that all medical information obtained during the course of the trial was considered confidential and used by BI in accordance with the local data protection law. Confidentiality of patient data was ensured by the use of depersonalised patient identification codes (patient numbers). In compliance with local legislation, trial sites in France did not collect information concerning patient race. The terms and conditions of the insurance cover were made available to the investigator and patients in the investigator site file (ISF).

Background therapy

Evidence for comparator

Actual start date of recruitment

02 Jul 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country