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Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels

This study has been completed.
Sponsor:
Information provided by:
Critical Biologics Corporation
ClinicalTrials.gov Identifier:
NCT00671307
First received: April 30, 2008
Last updated: September 27, 2010
Last verified: April 2010
History of Changes
  Purpose

This study is designed to assess the pharmacokinetics and safety of an infusion of a single dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the Intensive Care Unit with documented low levels of natural gelsolin. It is believed that this drug will raise the gelsolin levels in these patients and decrease the probability that they will develop complications from their underlying disease such as organ system failure or death.


Condition Intervention Phase
Low Gelsolin
Trauma
Infection
Burns
 Drug: rhu-pGelsolin
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1b Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Infusion Trial of the Pharmacokinetics of Rhu-pGelsolin in Patients With Decreased Natural Gelsolin Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Critical Biologics Corporation:

Primary Outcome Measures:
  • Pharmacokinetics of plasma gelsolin [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and the development of anti-rhu-pGelsolin antibodies [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics of sepsis biomarkers [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Clinical outcomes (mortality, duration of ICU stay, duration of ventilator support, duration of hospital stay) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Vehicle control given as IV infusion over 1 hour
Other Name: Vehicle control
Experimental: Low dose
3 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
 Drug: rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Other Names:
  • Recombinant plasma gelsolin
  • CBC-100
  • Solinex
Experimental: Mid-dose
6 mg/kg of rhu-pGelsolin given as an IV infusion over 1 hour
 Drug: rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Other Names:
  • Recombinant plasma gelsolin
  • CBC-100
  • Solinex
Experimental: High dose
6 mg/kg of rhu-pGelsolin given a an IV infusion over 1 hour once a day for 3 days
 Drug: rhu-pGelsolin
IV formulation of recombinant plasma gelsolin formulated as 10 mg/ml given as a single IV infusion over 1 hour
Other Names:
  • Recombinant plasma gelsolin
  • CBC-100
  • Solinex

Detailed Description:

This is a randomized, double-blind, placebo-controlled, ascending single dose of rhu-pGelsolin infusion study. Thirteen subjects (10 active and 3 placebo) will be dosed at 3 mg/kg and 5 subjects (3 active and 2 placebo) will be dosed at 6 mg/kg. In addition, twenty-two subjects (18 active and 4 placebo) will be dosed at 6 mg/kg per day for 3 days. The Data Safety Monitoring Committee (DSMC) and Steering Committee will review the preceding dose safety data, and agree the tolerability prior to the enrolment for next higher dose. Blood samples will be collected during 1 hour infusion through 72 hours post dose for PK assessment after each dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years of age
  • Documented gelsolin level <100 mg/mL
  • Admission to ICU
  • Women of child-bearing age have a negative pregnancy test
  • Multiple Organ Failure score < 4
  • Catheter present through which blood samples can be taken
  • Written Informed Consent obtained

Exclusion Criteria:

  • Participation in other investigational treatment protocols
  • Patients <18 years of age
  • Patients who have a modified Multiple Organ Failure score of >=4
  • Patient, who in the opinion of the Principal Investigator, are unlikely to be in the ICU for >48 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671307

Locations
Hong Kong
Queen Mary Hospital; University of Hong Kong
Hong Kong, SAR, Hong Kong
Sponsors and Collaborators
Critical Biologics Corporation
Investigators
Principal Investigator: Wai M Chan, MBBS Queen Mary Hospital, Hong Kong
Study Director: Selene Tam, PhD University of Hong Kong; Clinical Trials Centre
Study Chair: Richard C Straube, MD Critical Biologics Corporation
  More Information

Publications:

Responsible Party: Richard Straube, MD/ Chief Medical Officer, Critical Biologics Corporation
ClinicalTrials.gov Identifier: NCT00671307     History of Changes
Other Study ID Numbers: CBC101
Study First Received: April 30, 2008
Last Updated: September 27, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by Critical Biologics Corporation:
Gelsolin
Trauma
Pneumonia
Peritonitis
 Burn
Infection
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 19, 2013