A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis.



Status:Recruiting
Conditions:Pulmonary, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:November 27, 2017
End Date:July 31, 2021
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

The main objective is to assess long term safety of treatment with oral nintedanib in
patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).


Inclusion Criteria:

- Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not
permanently discontinue study treatment

- Signed and dated written informed consent in accordance with International Conference
on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial

- Women of childbearing potential must be ready and able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
year when used consistently and correctly as well as one barrier method for 28 days
prior to nintedanib treatment initiation, during the trial and for 3 months after last
intake of nintedanib.

- Further inclusion criteria apply

Exclusion Criteria:

- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of
Normal (ULN)

- Bilirubin > 2 x ULN

- Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.

- Clinically relevant anaemia at investigators discretion.

- Bleeding risk, any of the following

- Known genetic predisposition to bleeding according to the judgement of the
investigator

- Patients who require

- Fibrinolysis, full-dose therapeutic anticoagulation

- High dose antiplatelet therapy.

- Hemorrhagic central nervous system (CNS) event after completion of the parent
trial 1199.214/1199-0340

- Any of the following after last treatment of 1199.214/1199-0340:

- Haemoptysis or haematuria

- Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers

- Gastric antral vascular ectasia (GAVE)

- Major injury or surgery

- Coagulation parameters: International normalised ratio (INR) >2, prolongation of
prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at
Visit 1.

- New major thrombo-embolic events developed after completion of the parent trial
1199.214/1199-0340:

- Stroke;

- Deep vein thrombosis;

- Pulmonary embolism;

- Myocardial infarction.

- Major surgery performed within the next 3 months

- Time period > 12 weeks between last drug intake in 1199.214 or > 1 week between last
nintedanib intake in trial 1199-0340 and Visit 2 of this trial

- Usage of any investigational drug after completion of 1199.214/1199-0340 or planned
usage of an investigational drug during the course of this trial.

- A disease or condition which may put the patient at risk because of participation in
this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the
patient's ability to participate in this trial

- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
makes them an unreliable trial subject or unlikely to complete the trial

- Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial

- Previous enrolment in this trial

- Further exclusion criteria apply
We found this trial at
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: +001 (215) 955-1410
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Phone: +001 (617) 638-4312
Boston University School of Medicine A leader in medical education and research, Boston University School...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: +001 (216) 445-5429
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: +001 (319) 353-8862
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Los Angeles, California 90095
310-825-4321
Phone: +001 (310) 794-1996
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Miami, Florida 33124
(305) 284-2211
Phone: +001 (305) 243-3728
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: +001 (615) 343-7068
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Seattle, Washington 98104
(206) 543-2100
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Atlanta, Georgia 30322
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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726 Avenida Luis María Campos
Buenos Aires, C1426
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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303 East Superior Street
Chicago, Illinois 60611
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Falls Church, Virginia 22042
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Houston, Texas 77030
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Jacksonville, Florida 32209
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
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Minneapolis, Minnesota 55455
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333 Cedar St
New Haven, Connecticut 06504
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New Orleans, Louisiana 70112
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New York, New York 10032
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535 E 70th St
New York, New York 10021
(212) 606-1000
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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1428 Madison Ave
New York, New York 10029
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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3401 N Broad St
Philadelphia, Pennsylvania
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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1 Shields Ave
Sacramento, California 95616
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Salt Lake City, Utah 84132
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San Francisco, California 94143
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Seattle, Washington 98101
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300 Pasteur Dr
Stanford, California 94305
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
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