IGIV Study for Chronic ITP Patients Ages 3-70

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00511147
• Date of registration: 01/08/2007
• Prospective Registration: Yes
• Primary sponsor: Grifols Biologicals Inc.
• Public title: IGIV Study for Chronic ITP Patients Ages 3-70
• Scientific title: A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura
• Date of first enrolment: May 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00511147
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, India, Puerto Rico, United States

Contacts

• Name: Ali Khojasteh, MD
• Affiliation: Capitol Comprehensive Cancer Care Clinic

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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

Key Exclusion Criteria:

- 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



Age minimum: 3 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Biological: IGIV3I Grifols 10%

Primary Outcome(s)

Response Rate [Time Frame: 8 days]

Secondary Outcome(s)

Time to Platelet Count Recovery [Time Frame: 30 days]

Regression of Hemorrhage/Bleedings [Time Frame: 15 days]

Duration of Response [Time Frame: 30 days]

Secondary ID(s)

IG0601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto Grifols, S.A.

Results

• Results available: Yes
• Date Posted: 05/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00511147