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Primary Immune Deficiency DiseasePhase 4NCT00634569

Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

A Phase 4 study testing Flebogamma 5% DIF in people with Primary Immune Deficiency Disease, run by Instituto Grifols, S.A. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population. Read more about this study

Who is it for?
Ages 2 to 16 years
Conditions the study is for
Primary Immune Deficiency Disease
What is being tested?
Flebogamma 5% DIF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
7 sitesUnited States
Study dates
May 2008to May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 2 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The subject is between 2 and 16 years old, of either sex, belonging to any ethnic group, and above a minimum weight of 10 kg (this weight is based on the amount of blood required for testing).
  • The subject has a primary immunodeficiency disease, (e.g., common variable immunodeficiency, X-linked and autosomal forms of agammaglobulinemia, hyper-IgM syndrome, Wiskott-Aldrich Syndrome).
  • The subject has been receiving licensed IGIV replacement therapy at a dose that has not changed by + 50% of the mean dose on a mg/kg basis for at least 3 months before study entry and has maintained a trough level at least 300 mg/dL above baseline serum IgG levels.
  • Trough levels of IgG, dose of IGIV, and treatment intervals for the last 2 consecutive routine IGIV treatments must be documented for each subject before the first infusion in this study can be administered.
  • If a subject is an adolescent female (> 12 years of age) who is or becomes sexually active, she must have a negative result on a pregnancy test (HCG-based assay).
  • The subject, if old enough (generally 6 years to 16) has signed an informed Child Assent form and the subject's parent or legal guardian has signed an informed consent form, both approved by the Institutional Review Board.

Who cannot join

  • Adult patient (> 17 years old).
  • The subject has a history of any severe anaphylactic reaction to blood or any blood-derived product.
  • The subject is known to be intolerant to any component of the products, such as sorbitol (i.e., intolerance to fructose).
  • The subject has selective IgA deficiency or has demonstrable antibodies to IgA.
  • The subject is currently receiving, or has received, any investigational agent within the prior 3 months.
  • The subject has been exposed to blood or any blood product or derivative within the last 6 months, other than a commercially available IGIV.
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  • The adolescent subject is pregnant or is nursing.
  • The subject, at screening, has levels greater than 2.5 times the upper limit of normal as defined at the central laboratory for pediatric patients of any of the following:
  • ALT
  • AST
  • LDH
  • The subject has a severe pre-existing renal impairment (defined by serum creatinine greater than 2 times the ULN or BUN greater than 2.5 times the ULN for that laboratory, or any subject who is on dialysis) or any history of acute renal failure.
  • The subject has a history of DVT or thrombotic complications of IGIV therapy.
  • The subject suffers from any acute or chronic medical condition (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state) that, in the opinion of the Investigator, may interfere with the conduct of the study.
  • The subject has an acquired medical condition such as lymphocytic leukemia, chronic or recurrent neutropenia (ANC less than 1000), or AIDS known to cause secondary immune deficiency, or is s/p hematopoetic stem cell transplantation.
  • The subject is receiving the following medication:
  • Systemic corticosteroids (long-term, i.e., not intermittent or burst, daily, > 1 mg of prednisone equivalent/kg/day). Topical steroids (ie- nasal, inhaled for asthma, and/or skin preparations for eczema) are not exclusionary.
  • Immunosuppressive drugs
  • Immunomodulatory drugs
  • The subject has non-controlled arterial hypertension (systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg).
  • The subject has anemia (hemoglobin < 10 g/dL) at screening.
  • The subject and/or parent/legal guardian of the subject is unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative or unable to provide from the patient a storage serum sample at the screening visit. (Please note, a pre-treatment serum sample to be stored at -94° F (-70º C) for possible future testing is absolutely required).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Family Allergy & Asthma Center, PC

    Atlanta, Georgia, 30342

  • The Children's Hospital of Buffalo

    Buffalo, New York, 14222

  • Rush University Medical Center

    Chicago, Illinois

  • The Allergy and Asthma Center

    Fort Wayne, Indiana, 46804

  • Pennsylvania State University, Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Children's Hospital and Regional Medial Center

    Seattle, Washington, 98195-7110

  • University of South Florida

    St. Petersburg, Florida, 33701-4899

Other trials in United States

About this study

Official title: Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.

Being tested
Flebogamma 5% DIF
Keywords
CVID, XLA, hyper IgM syndrome, Wiskott-Aldrich Syndrome
Medical subject headings
Primary Immunodeficiency Diseases, Bruton type agammaglobulinemia, Hyper-IgM Immunodeficiency Syndrome, Wiskott-Aldrich Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flebogamma 5% DIFBiological

    Intravenous Immune Globulin (Human)

Study groups in NCT00634569
Study groupRoleWhat they receive
Flebogamma 5% DIFExperimentalNot described
Receives: Biological: Flebogamma 5% DIF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Bacterial Infections.

    Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis

    Measured: 12 months

Secondary outcomes (7)

  1. Days of School/Usual Activities Missed Per Year

    Mean Days of school/usual activities missed per subject/year

    Measured: 12 months

  2. Days of Hospitalization Per Year

    Mean Days of hospitalization per subject/year

    Measured: 12 months

  3. Number of Visits to Physician/ER Room for Acute Problems

    Mean Number of visits to physician/ER room for acute problems

    Measured: 12 months

  4. Other Infections Documented by Fever and Physical Exam or Positive Radiograph.

    Measured: 12 months

  5. Number of Infectious Episodes Per Year

    Mean Number of infectious episodes per subject/year

    Measured: 12 months

  6. Number of Days on Antibiotics (Prophylactic and Therapeutic).

    Median Combined number of days on prophylactic and therapeutic antibiotics

    Measured: 12 months

  7. Number of Adverse Events

    Total Number of Adverse Events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2011
  4. Study completionMay 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00634569
Sponsor's protocol ID
IG-0705
Status last verified
Dec 2016
First submitted
5 Mar 2008
Last updated
2 Feb 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Flebogamma 5% DIF in people with Primary Immune Deficiency Disease, run by Instituto Grifols, S.A. at 7 sites 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 6 inclusion and 22 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: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Bacterial Infections. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00634569.

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 2 Feb 2017.

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