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COMPLETED Phase 3

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

NCT02851407 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Defibrotide
  • OTHER Best Supportive Care

Study Locations (20)

California

  • Children's Hospital Los Angeles — Los Angeles
  • Stanford University — Palo Alto
  • Rady Childrens Hospital San Diego — San Diego
  • University of California San Francisco — San Francisco

New York

  • Columbia University Medical Center — New York
  • Weill Cornell Medical College — New York
  • Memorial Sloan Kettering Cancer Center — New York

Arizona

  • Phoenix Children's Hospital — Phoenix
  • University of Arizona Cancer Center — Tucson

Florida

  • Nicklaus Childrens Hospital — Miami
  • Johns Hopkins All Children's Hospital — St. Petersburg

Massachusetts

  • Tufts Floating Hospital for Children — Boston
  • Dana Farber Cancer Institute — Boston

Alabama

  • Children's Hospital of Alabama — Birmingham

Colorado

  • Colorado Children's Hospital — Aurora

Delaware

  • Alfred I Dupont Hospital For Children — Wilmington

Trial Details

FieldValue
Enrollment Target 372 participants
Start Date 2016-09-01
Est. Completion 2020-10-20
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02851407

The ClinicalTrials.gov registry entry for NCT02851407 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Veno-occlusive Disease appearing as the primary indexed condition, and to 2 interventions — of which Defibrotide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02851407 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02851407 about?

NCT02851407 is a clinical study titled "Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients". 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 r...

What is the current status of trial NCT02851407?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2016-09-01. Estimated completion is 2020-10-20.

What conditions does trial NCT02851407 study?

This clinical trial studies the following conditions: Veno-occlusive Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02851407?

The interventions under investigation include: Defibrotide (DRUG), Best Supportive Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02851407?

This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02851407 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial