NCT00415311

Brief Summary

This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

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

Study Start

First participant enrolled

December 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

December 20, 2006

Last Update Submit

August 8, 2011

Conditions

Liver Transplantation

Keywords

Liver TransplantationrhMBL

Outcome Measures

Primary Outcomes (1)

  • Determine the safety and tolerability of rhMBL administered i.v. at doses of 0.5 and 1.0 mg/kg, as 8 weekly doses over 8 weeks, in the setting of liver transplantation

    3 months

Secondary Outcomes (4)

  • Determine the pharmacokinetic (PK) profile of rhMBL

    3 months

  • Determine the pharmacodynamics (PD) (complement deposition) of rhMBL

    3 months

  • Determine the immunogenicity of rhMBL by testing for the presence of anti-rhMBL antibodies

    3 months

  • Detect preliminary evidence of activity of rhMBL by analyzing the incidence of infectious complications.

    3 months

Study Arms (3)

0 mg/kg

OTHER
Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

0.5 mg/kg

OTHER
Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

1.0 mg/kg

OTHER
Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Interventions

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)DRUG

Intravenous(i.v.) administration for 8 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

0 mg/kg

Eligibility Criteria

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

You may qualify if:

  • Capable of understanding the protocol requirements and risks and providing written informed consent.
  • Scheduled to undergo OLT or LRD liver transplantation (single organ). Split grafts will not be allowed from OLT donors.
  • Donor has an MBL genotype of A/O or O/O.
  • Age ≥18 years old.
  • Willing to receive transfusions of blood products.
  • Any patient who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the genetic part of the study.

You may not qualify if:

  • Concurrent serious medical illness, in the judgment of the principal investigator (PI), which could potentially interfere with protocol compliance.
  • Positive screening pregnancy test or is breast-feeding.
  • Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during this study.
  • Any condition that, in the opinion of the PI or Enzon makes the patient unsuitable for the study.
  • Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first dose of rhMBL.
  • Prior liver transplants.
  • Systemic chemotherapy within 1 year before liver transplantation.
  • Serum creatinine \>5 mg/dL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198-7400, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Vanderbilt University

Nashville, Tennessee, 372321, United States

Location

Study Officials

  • Alison Freifeld, MD

    University of Nebraska Medical Center, 985400 Nebraska Medical Center, Omaha, NE 68198-5400

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

US(4)