Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)

NCT01417156 | Completed Phase 2 Results

• 1 other identifier: 1199.40
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Overall Adverse Events

  Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.

  First drug administration until end of treatment, up to 5 years

Secondary Outcomes (4)

• Annual Rate of Decline in Forced Vital Capacity (FVC).

  Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years

• Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

  Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years

• Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.

  First drug administration until end of treatment, up to 5 years

• Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.

  Week 234

Study Arms (1)

All patients

EXPERIMENTAL

Drug: Nintedanib; Drug: Pirfenidoneone

Interventions

Nintedanib DRUG

150 mg bid

All patients

Pirfenidoneone DRUG

Existing treatment

All patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent consistent with Good Clinical Practice (GCP) signed prior to entry into the study
• Completion of 1199.31 study and still under treatment with pirfenidone at a stable dose

You may not qualify if:

• Any other investigational therapy received within 8 weeks before visit 1.
• For female: Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for both at least 4 weeks prior to enrolment and 10 weeks after last study drug intake.
• For male: Sexually active males not committing to using condoms both during the course of the study and ten weeks after last study drug intake (except if their partner is not of childbearing potential).
• Known or suspected active alcohol or drug abuse.
• Patients who require full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, heparin), except low dose heparin and/or heparin flash as needed for maintenance of an indwelling intravenous device. As an example, prophylactic use of heparin, e.g. enoxaparin 2000 International unit (I.U.) subcutaneously (s.c.) per day, should be allowed.
• Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel) therapy. As an example, chronic low-dose acetyl salicylic acid, below or equal to 100 mg per day, should be allowed.
• Patient not compliant in previous trial, with trial medication or trial visits.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

Boehringer Ingelheim Investigational Site

Sakai, Osaka, Japan

Location

Boehringer Ingelheim Investigational Site

Seto, Aichi, Japan

Location

Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Annual ROD in FVC results to be interpreted with caution \& along with descriptive statistics as inferences used might not be valid as suggested by skewed distribution of data thus Absolute Change from baseline in FVC over time has been defined.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

JP (4)