NCT01547078

Brief Summary

A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 10, 2012

Last Update Submit

March 17, 2015

Conditions

Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Assess and compare adverse events

    The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control.

    Duration of Study (Less than or equal to 7 days)

Study Arms (2)

Licensed Plasma

ACTIVE COMPARATOR
Biological: Licensed Plasma

Lyophilized Plasma

EXPERIMENTAL
Biological: Lyophilized Plasma

Interventions

Lyophilized PlasmaBIOLOGICAL

Licensed plasma that has been lyophilized.

Lyophilized Plasma
Licensed PlasmaBIOLOGICAL

Plasma that has been authorized for transfusion.

Licensed Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients at least 18 years of age.
  • Patients with liver disease.
  • Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
  • Patients with an elevated international normalized ratio due to liver disease.
  • Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
  • Patients able and willing to comply with the procedures laid out in the study protocol.

You may not qualify if:

  • Patients who are clinically unstable.
  • Patients who have received mediations that could interfere with results of laboratory testing.
  • Patients who have congenital or acquired coagulopathies of non-hepatic origin.
  • Pregnant or nursing women.
  • Active illicit drug use.
  • Patients previously enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

March 7, 2012

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 18, 2015

Record last verified: 2015-03