Evaluation of Efficacy and Tolerability of Hizentra®

NCT01354587 | Unknown DMC

• 1 other identifier: Hizentra
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.

Conditions

Primary Immunodeficiency Disorders

Keywords

immunodeficiency

Outcome Measures

Primary Outcomes (1)

• To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.

  Subjects complete the TSQM at each study visit

  32 weeks

Secondary Outcomes (2)

• To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.

  32 weeks

• To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.

  32 weeks

Study Arms (1)

Hizentra

ACTIVE COMPARATOR

Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra

Drug: Hizentra

Interventions

Hizentra DRUG

Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.

Hizentra

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• year to 75 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

St. Petersburg, Florida, 33701, United States

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases

Study Officials

• John Sleasman, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Duff, MSN

CONTACT

7275533515; cduff@health.usf.edu

Amy Baldwin

CONTACT

7275531258; abaldwin@health.usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: May 17, 2011
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

US (1)