Evaluation of Efficacy and Tolerability of Hizentra® | NCT01354587

Studies
Evaluation of Efficacy and Tolerability of Hizentra®

NCT01354587

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Jul 17, 2012Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Primary Immunodeficiency Disorders

Interventions

Hizentra

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Mar 18, 2011

First Submission Date that Met QC Criteria

May 16, 2011

First Posted Date

May 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2012

Last Update Posted Date

Jul 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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®.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hizentra	Active Comparator	Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra	Drug: Hizentra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hizentra	Drug	Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.	Hizentra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.	Study subjects complete a weekly infusion diary that is collected at each study visit.	32 weeks
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carla Duff, MSN	Contact	7275533515		cduff@health.usf.edu
Amy Baldwin	Contact	7275531258		abaldwin@health.usf.edu

Overall Officials

Name	Affiliation	Role
John Sleasman, MD	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida	Recruiting	St. Petersburg	Florida	33701	United States

Condition Browse Module

MeSH Terms

ID	Term
D000081207	Primary Immunodeficiency Diseases
D007153	Immunologic Deficiency Syndromes

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided