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

Use our guide to learn which trials are right for you!

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
40
sites
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: +001 (843) 792-4349
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: +001 (205) 975-6770
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Phone: +001 (206) 598-4967
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Atlanta, Georgia 30322
Phone: +001 (404) 712-7458
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: +001 (303) 667-6597
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: +001 (410) 550-6819
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
726 Avenida Luis María Campos
Buenos Aires, C1426
Phone: +54 11 4576 5737 ext. 9546
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Phone: +001 (312) 695-1879
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: +001 (513) 558-4831
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: +001 (214) 645-6493
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: +001 (919) 684-4499
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Falls Church, Virginia 22042
Phone: +001 (703) 776-2256
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Houston, Texas 77030
Phone: +001 (713) 500-6905
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
Phone: +001 (904) 244-1106
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: +001 (913) 588-6046
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Phone: +001 (414) 955-7029
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
Phone: +001 (612) 624-0999
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: +001 (203) 785-7324
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
Phone: +001 (504) 988-4040
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
Phone: +001 (212) 342-4412
?
mi
from
New York, NY
Click here to add this to my saved trials
535 E 70th St
New York, New York 10021
(212) 606-1000
Phone: +001 (212) 774-2048
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: +001 (212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: +001 (215) 955-1410
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: +001 (215) 662-3202
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Phone: +001 (215) 707-8113
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: +001 (507) 266-2497
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Phone: +001 (916) 734-3643
University of California-Davis As we begin our second century, UC Davis is poised to become...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: +001 (314) 454-8763
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Phone: +001 (801) 581-5811
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
Phone: +001 (415) 502-1958
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Phone: +001 (206) 223-6622
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: +001 (650) 723-7409
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Phone: +001 (419) 383-4271
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
?
mi
from
Toledo, OH
Click here to add this to my saved trials
3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: +001 (202) 444-6200
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
?
mi
from
Washington,
Click here to add this to my saved trials