Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Grifols Biologicals, LLC
With
Instituto Grifols, S.A.
Age
3–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of chronic ITP
Platelet count ≤ 20 x 10\^9/L
When administered corticosteroids at any time within 3 weeks before screening visit, the subject must have completed at least 3 weeks (21 days) of therapy at a stable and constant dose and schedule prior to screening visit
When administered azathioprine (immunosuppressant) at any time within 3 months before screening visit, the subject must have received a stable dose and schedule for at least 3 months prior to screening visit
When administered vinca alkaloids (eg., vincristine) at any time within 2 weeks before screening visit, the subject must have received a stable dose and schedule for at least 2 weeks prior to screening visit
When administered attenuated androgens (eg, danazol) at any time within 8 weeks before screening visit, the subject must have received a stable dose and schedule for at least 8 weeks prior to screening visit.
Females of childbearing potential must test negative for pregnancy
You may not be if
History or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia
Diagnosis of secondary immune thrombocytopenia
History of severe (eg, anaphylactic) reactions to blood or any blood- derived product
History of intolerance to any component of the IP, such as sorbitol
Suffering serious and/or life-threatening hemorrhage/bleeding defined as:
Any intracranial or central nervous system bleeding
Any hemorrhagic event in which the subject is at risk of death at the time of the event
Females who are pregnant or nursing an infant child
Known to have immunoglobulin A (IgA) deficiency
Known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or has done so within 12 months of the screening visit
Documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past
Unstable or uncontrolled disease, or condition, related to, or impacting, cardiac function: unstable angina, congestive heart failure, uncontrolled arterial hypertension
Is anemic (hemoglobin \< 9 g/dL)
Renal impairment (ie, serum creatinine \> 1.5 x upper limit of normal \[ULN\])
Aspartate aminotransferase or alanine aminotransferase levels \> 2.5 x ULN
Known to have a positive test for either HCV or HIV (HIV 1/2)
Splenectomy within the prior 8 weeks to the screening visit
currently receiving any treatment for ITP except corticosteroids, azathioprine, vinca alkaloids or danazol
Received an immune serum globulin (ISG) product within the prior 3 weeks (21 days) to the screening visit
Received any alkylating agent (eg, cyclophosphamide) within 5 weeks prior to the screening visit
Received rituximab within the prior 3 months to the screening visit
Was currently receiving, or received, any therapeutic drug or device that was not approved by a Regulatory Authority (US or Canadian) for any indication within the prior 12 weeks to the screening visit
Clareo Health | IGIV Study for Chronic ITP Patients Ages 3-70
