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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01354587
Date of registration: 18/03/2011
Prospective Registration: No
Primary sponsor: University of South Florida
Public title: Evaluation of Efficacy and Tolerability of Hizentra®
Scientific title: Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)
Date of first enrolment: October 2010
Target sample size: 50
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01354587
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Carla Duff, MSN
Address: 
Telephone: 727-553-3515
Email: cduff@health.usf.edu
Affiliation: 
Name:     Carla Duff, MSN
Address: 
Telephone: 7275533515
Email: cduff@health.usf.edu
Affiliation: 
Name:     John Sleasman, MD
Address: 
Telephone:
Email:
Affiliation:  USF
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects currently self-infusing with Vivaglobin® for at least six months prior to
enrollment.

- Diagnosis of antibody deficiency due to primary immune deficiency disease.

- Stable serum IgG levels of > 550 mg/dl while on Vivaglobin® based on two
determinations at least 8 weeks apart and obtained within 6 months of entry.

- Willing to sign consent and follow study schedule.

- 1 year to 75 years of age.

Exclusion Criteria:

- Evidence of acute systemic illness or infection at within four weeks of screening or
enrollment.

- Any serious grade 3 or greater toxicity at screening.

- History of bleeding or chronic skin disorders.

- Selective IgA deficiency in absence of other antibody deficiencies

- History of anaphylactic or severe systemic reaction to Vivaglobin.

- Pregnant or breastfeeding females.

- Use of systemic pre-medication prior to SCIG.

- Protein losing enteropathy or nephritic syndrome.

- Any condition that in the opinion of the investigator would interfere with the
conduct of the study.

- Subject or guardian unwilling to sign consent or adhere to study schedule.



Age minimum: 1 Year
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Primary Immunodeficiency Disorders
Intervention(s)
Drug: Hizentra
Primary Outcome(s)
To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®. [Time Frame: 32 weeks]
Secondary Outcome(s)
To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [Time Frame: 32 weeks]
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [Time Frame: 32 weeks]
Secondary ID(s)
Hizentra
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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