Primary Immunodeficiency DisordersNCT01354587
Evaluation of Efficacy and Tolerability of Hizentra®
A study testing Hizentra in people with Primary Immunodeficiency Disorders, run by University of South Florida at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Primary Immunodeficiency Disorders
- What is being tested?
- Hizentra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
St. Petersburg, Florida, 33701
Carla Duff, MSN, 727-553-3515, cduff@health.usf.edu
Amy Baldwin, 7275531258, abaldwin@health.usf.edu
About this study
Official title: Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)
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®.
Read the 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
- Being tested
- Hizentra
- Keywords
- immunodeficiency
- Medical subject headings
- Primary Immunodeficiency Diseases, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HizentraDrug
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hizentra | Active comparator | Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra Receives: Drug: Hizentra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 weeks
Secondary outcomes (2)
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.
Measured: 32 weeks
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
IgG levels are obtained at each visit.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency DisordersStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Sleasman, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354587
- Sponsor's protocol ID
- Hizentra
- Status last verified
- Jul 2012
- First submitted
- 18 Mar 2011
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)
- ClinicalTrials.gov ID
- NCT01354587
- Acronym / sponsor ID
- Hizentra
- Conditions
- Primary Immunodeficiency Disorders
- Keywords
- immunodeficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hizentra | Active comparator | Drug: HizentraCompare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HizentraSubjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks. | Drug | Hizentra |
Primary outcome
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
2 secondary outcomes
To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
Time frame: 32 weeks
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sleasman, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hizentra in people with Primary Immunodeficiency Disorders, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Duff, MSN (7275533515, cduff@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.