Recruiting

Hizentra

Sponsor:

University of South Florida

Code:

NCT01354587

Conditions

Primary Immunodeficiency Disorders

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Interventions

Hizentra

Study Details

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

Study ID

NCT01354587

Start date

Oct, 2010

Status verified date

Jul, 2012

Completion date

Aug, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hizentra

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

Interventions

Hizentra

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

Primary outcome measure

  • To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®. [ Time Frame: 32 weeks ]

Central Contacts and Locations

Central contacts

Carla Duff, MSN

7275533515cduff@health.usf.edu

Amy Baldwin

7275531258abaldwin@health.usf.edu

Locations

University of South Florida

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Carla Duff, MSN

727-553-3515cduff@health.usf.edu

Amy Baldwin

7275531258abaldwin@health.usf.edu

Principal Investigator:

John Sleasman, MD

More Information

Sponsor

University of South Florida

Last update posted

Jul 17, 2012

Last verified

Jul, 2012

Keywords

  • immunodeficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2012-07-17.