Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01581593
• Date of registration: 16/04/2012
• Prospective Registration: Yes
• Primary sponsor: Kedrion S.p.A.
• Public title: Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
• Scientific title: Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).
• Date of first enrolment: November 2012
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01581593
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Mirella Calcinai, MD
• Affiliation: Kedrion, SpA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed clinical diagnosis of a Primary Immunodeficiency Disease

- Male or female, ages 2 to 70 years

- Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at
least 3 months prior to this study

- 2 documented IgG trough levels of = 5 g/L are obtained at two infusion cycles (21 or
28 days) within 12 months (one must be within 6 months) prior to study enrolment

- Non-pregnant females of child-bearing potential who agree to use adequate birth
control during the study

- Subject is willing to comply with the protocol

- Authorization to access personal health information.

- Signed the informed consent form and a child assent form, if appropriate.

- If currently participating in a clinical trial with another experimental IVIG may be
enrolled if they have received stable IVIG therapy for at least 3 infusion cycles
prior to receiving Kedrion IVIG 10% and all inclusion and exclusion criteria are
satisfied

- If currently participating in a trial of SCIG can be enrolled if they are switched to
IVIG for three infusion cycles (21 or 28 days) prior to enrolment in this study

Exclusion Criteria:

- Has secondary immunodeficiency.

- Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed
with dysgammaglobulinemia or isolated IgG subclass deficiency.

- Has a history of repeated reactions or hypersensitivity to IVIG or other injectable
forms of IgG.

- Has a history of thrombotic events defined by at least 1 event in subject's lifetime.

- Has IgA deficiency and is known to have antibodies to IgA.

- Has received blood products other than human albumin or human immunoglobulin within
12 months prior to enrolment.

- Has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.

- Has an acute infection as documented by culture or diagnostic imaging and/or a body
temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening

- Has a known history or is positive at enrolment for human immunodeficiency virus
(HIV) type 1 by NAT, hepatitis B virus (HBsAg and NAT), hepatitis C virus (by NAT),
or hepatitis A virus (by NAT).

- Has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >
2.5 times of the upper limit of normal for the laboratory designated for the study.

- Has an implanted venous access device

- Has profound anemia or persistent severe neutropenia (= 1000 neutrophils per mm3)or
lymphopenia of less than 500 cells per microliter.

- Has a severe chronic condition such as renal failure (creatinine concentration > 2.0
times the upper limit of normal) with proteinuria, congestive heart failure (New York
Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with
thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart
disease, hyperviscosity, or any other condition that the investigator believes is
likely to interfere with evaluation of the study drug or with satisfactory conduct of
the trial.

- Has a history of a malignant disease other than properly treated carcinoma in situ of
the cervix or basal cell or squamous cell carcinoma of the skin within 24 months
prior to enrolment.

- Has history of epilepsy or multiple episodes of migraine (defined as at least one
episode within 6 months of enrolment) not completely controlled by medication.

- Is receiving steroids (oral or parenteral daily dose of = 0.15 mg/kg/day of
prednisone or equivalent) OR other immunosuppressive drugs or chemotherapy.

- Females who are pregnant, breast feeding or planning a pregnancy during the course of
the study. Women who become pregnant during the study will be withdrawn from the
study.

- Has participated in another clinical study within 3 weeks prior to study enrolment.



Age minimum: 2 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Agammaglobulinemia

Antibody Deficiency

Hypogammaglobulinemia

Primary Immunodeficiency

Intervention(s)

Biological: Kedrion IVIG 10%

Primary Outcome(s)

Incidence of acute, serious bacterial infections [Time Frame: 13 months]

Secondary Outcome(s)

Incidence of decreased infusion rate due to adverse events [Time Frame: 13 months]

Evidence of change in daily activities due to infections [Time Frame: 13 months]

Incidence of adverse events [Time Frame: 13 months]

IgG serum levels [Time Frame: every month up to 13 months]

Incidence of infections other than acute, serious bacterial infections [Time Frame: 13 months]

Secondary ID(s)

KB052

Source(s) of Monetary Support

Please refer to primary and secondary sponsors