Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:1/27/2019
Start Date:September 2016
End Date:February 2021
Contact:Clinical Trial Information Desk
Email:HarmonyTrialInfo@jazzpharma.com

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A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to
best supportive care versus best supportive care alone in the prevention of hepatic veno-
occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell
transplant who are at high risk or very high risk of developing VOD.


Inclusion Criteria:

1. Patient must be above the age of 1 month as of the start date of study treatment.

2. Patient must be scheduled to undergo allogeneic hematopoietic stem cell transplant
(HSCT) (adults or pediatric patients) or autologous HSCT (pediatric patients only) and
be at high risk or very high risk of developing veno-occlusive disease (VOD).

3. Female patients (and female partners of male patients) of childbearing potential who
are sexually active must agree to use a highly effective method of contraception with
their partners during exposure to defibrotide and for 1 week after the last dose of
defibrotide.

4. Adult patients must be able to understand and sign a written informed consent. For
minor patients, the parent/legal guardian or representative must be able to understand
and sign a written informed consent. Assent, when appropriate, will be obtained
according to institutional guidelines.

Exclusion Criteria:

1. Patient has hemodynamic instability within 24 hours before the start of study
treatment.

2. Patient has acute bleeding that is clinically significant within 24 hours before the
start of study treatment.

3. Patient used any medication that increases the risk of bleeding within 24 hours before
the start of study treatment.

4. Patient is using or plans to use an investigational agent for the prevention or
treatment of VOD.

5. Patient, in the opinion of the investigator, may not be able to comply with the safety
monitoring requirements of the study.

6. Patient or parent/legal guardian or representative has a psychiatric illness that
would prevent the patient or parent/legal guardian or representative from giving
informed consent and/or assent.

7. Patient has a serious active disease or co-morbid medical condition, as judged by the
investigator, which would interfere with the conduct of this study.

8. Patient is pregnant or lactating and does not agree to stop breastfeeding.

9. Patient has a known history of hypersensitivity to defibrotide or any of the
excipients.

10. Patient or parent/legal guardian or representative lacks the full mental capacity to
understand and sign a written informed consent.

11. Patient is receiving or plans to receive other investigational therapy during study.
We found this trial at
40
sites
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Rajinder Bajwa
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Frederick Goldman
Children's Hospital of Alabama Children
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Rabi Hanna
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Rakesh Goyal
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Araz Marachelian
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Renee Madden
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Carrie Kitko
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Stephan Grupp
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Eric Anderson
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Ann Woolfrey
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Emi Caywood, MD
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Adelaide, South Australia
Principal Investigator: Devendra Hiwase
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Elizabeth Stenger
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Aurora, Colorado 80045
Principal Investigator: Roger Giller
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800 Washington Street
Boston, Massachusetts 02111
Principal Investigator: Jason Law, MD
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Bronx, New York 10467
Principal Investigator: David Loeb, MBChB
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
Principal Investigator: Michelle Hudspeth
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Reggie Duerst
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cleveland, Ohio 44106
Principal Investigator: Jignesh Dalal
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Tiffany Simms-Waldrip
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Sureyya Savasan
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Fort Worth, Texas 76104
Principal Investigator: Meaghan Granger
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Robert Greiner, MD
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6621 Fannin St
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(832) 824-1000
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Houston, Texas 77030
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: David Margolis
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630 W 168th St
New York, New York
212-305-2862
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New York, New York 10021
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1275 York Ave
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(212) 639-2000
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Palo Alto, California 94304
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1919 E Thomas Rd
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Saint Petersburg, Florida 33701
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San antonio, Texas 78229
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Tucson, Arizona 85724
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