Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

NCT01170065 | Completed Phase 2 Results

• 2 other identifiers: 1199.352009-013788-21
• Study Type: interventional
• Target: 198
• Locations: 21 countries
• Sites: 57

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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

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

  Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.

  From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

Secondary Outcomes (7)

• Overall Survival

  From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

• Progression-Free Survival

  From first trial drug intake in 1199.35 to disease progression; up to 61.8 months

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

  From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

• Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

  From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

• Incidence of Patients With at Least One Acute IPF Exacerbation Over Time

  From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months

Study Arms (4)

BIBF 1120 low qd

EXPERIMENTAL

Low dose BIBF 1120 once daily

Drug: BIBF 1120

BIBF 1120 low bid

EXPERIMENTAL

Low dose BIBF 1120 twice daily

Drug: BIBF 1120

BIBF 1120 medium bid

EXPERIMENTAL

Intermediate dose BIBF 1120 twice daily

Drug: BIBF 1120

BIBF 1120 high bid

EXPERIMENTAL

High dose BIBF 1120 twice daily

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

Intermediate dose BIBF 1120 twice daily

BIBF 1120 medium bid

Eligibility Criteria

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

You may qualify if:

• Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
• Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
• Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)

You may not qualify if:

• Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
• Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
• Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
• Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
• Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
• Known or suspected active alcohol or drug abuse.
• Patient not compliant in previous trial, with trial medication or trial visits.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (57)

INSARES

Mendoza, M5500CCG, Argentina

Location

Respiratory Clinical Trial Pty Ltd.

Glen Osmond, South Australia, 5064, Australia

Location

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Royal Perth Hospital-Lung Transplant Unit

Perth, Western Australia, 6000, Australia

Location

ULB Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Yvoir - UNIV UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, CEP90035-0, Brazil

Location

Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic

Sofia, 1431, Bulgaria

Location

QEII Health Sciences Centre (Dalhousie University)

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Instituto Nacional del Tórax

Santiago, 7500000, Chile

Location

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

University Hospital Na Bulovce, Prague

Prague, 180 81, Czechia

Location

Masaryk Hospital, Usti nad Labem

Ústí nad Labem, 401 13, Czechia

Location

HOP Avicenne

Bobigny, 93009, France

Location

HOP Dijon, Pneumo, Dijon

Dijon, 21079, France

Location

HOP Calmette

Lille, 59037, France

Location

HOP Arnaud de Villeneuve

Montpellier, 34295, France

Location

HOP Pasteur

Nice, 06002, France

Location

HOP Bichat

Paris, 75877, France

Location

Klinik Donaustauf

Donaustauf, 93093, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Universitätsklinikum Freiburg

Freiburg/Breisgau, 79106, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München - Campus Großhadern

München, 81377, Germany

Location

University General Hospital of Evros

Alexandroupoli, 68100, Greece

Location

University Hospital of Heraklion, University Pulmonology Cl

Heraklion, 71100, Greece

Location

Csongrad County's Hosp.

Deszk, 6772, Hungary

Location

University of Pecs, 1st internal Med. Dept., Pulmonology

Pécs, 7623, Hungary

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Ospedale C. G. Mazzoni

Ascoli Piceno, 63100, Italy

Location

Osp. S. Giuseppe Fatebenefratelli

Milan, 20123, Italy

Location

Università di Modena e Reggio Emilia

Modena, 41100, Italy

Location

Università Federico II

Napoli, 80131, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, 53100, Italy

Location

Università di Perugia

Terni, 05100, Italy

Location

Ospedale di Cattinara

Trieste, 34100, Italy

Location

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

Distrito Federal, 14080, Mexico

Location

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, 3041-801, Portugal

Location

CHLN, EPE - Hospital de Santa Maria

Lisbon, 1064-035, Portugal

Location

Centro Hospitalar Lisboa Norte Hospital Pulido Valente

Lisbon, 1750-001 L, Portugal

Location

Centro Hospitalar São João,EPE

Porto, 4202-451, Portugal

Location

Central Scientific Research Insitute of Tuberculosis

Moscow, 107564, Russia

Location

Scientific Research Institute of Pulmonology

Saint Petersburg, 197089, Russia

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Dr. Peset

Valencia, 46017, Spain

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Southmead Hospital

Westbury on Trym, BS10 5NB, United Kingdom

Location

Related Publications (1)

• Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

  PMID: 28993537 DERIVED

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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 27, 2010
• Study Start: June 25, 2010
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-02

Locations

AR (1); RU (2); CZ (2); GB (4); CL (1); GR (2); CA (2); FR (6); NL (1); DE (6); CN (4); AU (3); BE (3); BU (1); BR (1); HU (2); IT (8); IE (1); ME (1); PT (4); ES (2)