Evaluation of Efficacy and Tolerability of Hizentra®
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ClinicalTrials.gov Identifier: NCT01354587 |
Recruitment Status : Unknown
Verified July 2012 by University of South Florida.
Recruitment status was: Recruiting
First Posted : May 17, 2011
Last Update Posted : July 17, 2012
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Condition or disease | Intervention/treatment | Phase |
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Primary Immunodeficiency Disorders | Drug: Hizentra | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product) |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | August 2012 |
Estimated Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Hizentra
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
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Drug: Hizentra
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks. |
- To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®. [ Time Frame: 32 weeks ]Subjects complete the TSQM at each study visit
- To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [ Time Frame: 32 weeks ]Study subjects complete a weekly infusion diary that is collected at each study visit.
- To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [ Time Frame: 32 weeks ]IgG levels are obtained at each visit.

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Ages Eligible for Study: | 1 Year to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354587
Contact: Carla Duff, MSN | 7275533515 | cduff@health.usf.edu | |
Contact: Amy Baldwin | 7275531258 | abaldwin@health.usf.edu |
United States, Florida | |
University of South Florida | Recruiting |
St. Petersburg, Florida, United States, 33701 | |
Contact: Carla Duff, MSN 727-553-3515 cduff@health.usf.edu | |
Contact: Amy Baldwin 7275531258 abaldwin@health.usf.edu | |
Principal Investigator: John Sleasman, MD | |
Sub-Investigator: Carla Duff, MSN |
Principal Investigator: | John Sleasman, MD | University of South Florida |
Responsible Party: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT01354587 |
Other Study ID Numbers: |
Hizentra |
First Posted: | May 17, 2011 Key Record Dates |
Last Update Posted: | July 17, 2012 |
Last Verified: | July 2012 |
immunodeficiency |
Primary Immunodeficiency Diseases Immunologic Deficiency Syndromes Immune System Diseases Genetic Diseases, Inborn |