Evaluation of Efficacy and Tolerability of Hizentra®

NCT ID: NCT01354587

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-08-31

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®.

Detailed Description

This trial will evaluate subjects with Primary Immunodeficiency Disorder (PIDD) who are currently self-infusing Vivaglobin therapy for at least six months prior to changing to Hizentra® therapy. Following screening and enrollment, subjects will continue to self-infuse Vivaglobin® for seven infusions and then be converted to subcutaneous Hizentra® treatment which they will continue for the next 6 months. The study will determine if Hizentra® provides improved subject satisfaction by Treatment Satisfaction Questionnaire for Medication. Diaries related to the local site reactions, the number of infusion sites per subject/per dose, volume of Hizentra® per site, duration of infusions, systemic side effects of the new medication and dose on IgG levels and antibody titers, and local site reactions with Hizentra®.

Conditions

Primary Immunodeficiency Disorders

Keywords

immunodeficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hizentra

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

Group Type: ACTIVE_COMPARATOR

Hizentra

Intervention Type: DRUG

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

Interventions

Hizentra

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Sleasman, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

St. Petersburg, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla Duff, MSN

Role: CONTACT

Phone: 7275533515

Email: cduff@health.usf.edu

Amy Baldwin

Role: CONTACT

Phone: 7275531258

Email: abaldwin@health.usf.edu

Facility Contacts

Carla Duff, MSN

Role: primary

Amy Baldwin

Role: backup

Other Identifiers

Hizentra

Identifier Type: -

Identifier Source: org_study_id