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
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Palo Alto, California 94304
Principal Investigator: Rajni Agarwal-Hashmi
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1600 7th Avenue
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
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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
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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
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2220 Pierce Ave
Nashville, Tennessee 37232
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South 34th Street
Philadelphia, Pennsylvania 19104
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3020 Childrens way
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1100 Fairview Avenue North
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1600 Rockland Road
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Adelaide, South Australia
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1405 Clifton Road NE
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Aurora, Colorado 80045
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800 Washington Street
Boston, Massachusetts 02111
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Bronx, New York 10467
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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225 E Chicago Ave
Chicago, Illinois 60611
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Cleveland, Ohio 44106
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1935 Medical District Dr
Dallas, Texas 75235
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3901 Beaubien St
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2301 Erwin Rd
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Fort Worth, Texas 76104
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500 University Dr
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6621 Fannin St
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
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630 W 168th St
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New York, New York 10021
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1919 E Thomas Rd
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