This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

IGIV Study for Chronic ITP Patients Ages 3-70

This study has been completed.
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00511147
First received: August 1, 2007
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count < 150 x 10^9/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic ITP.

Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura Biological: IGIV3I Grifols 10% Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 8 days ]
    Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L by Day 8 ± 1 [where the day of the first infusion is Day 1]


Secondary Outcome Measures:
  • Time to Platelet Count Recovery [ Time Frame: 30 days ]
    Defined by the number of days elapsed from Day 1 (the day of the first infusion of the IP) to the day when the platelet count is first known to be ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1

  • Duration of Response [ Time Frame: 30 days ]
    Defined by the number of consecutive days for which the platelet count remains ≥ 50 x 10^9/L at any moment during the clinical follow-up period ending on Day 30 ± 1.

  • Regression of Hemorrhage/Bleedings [ Time Frame: 15 days ]
    Defined by the percentage of treated patients with hemorrhage/bleedings at Day 1 (i.e., the day of the first infusion, pre-infusion) who improve their diathesis during the clinical follow-up period ending on Day 15 ± 1.


Enrollment: 64
Study Start Date: May 2008
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGIV3I Grifols 10% (All Subjects)
All subjects with Chronic ITP
Biological: IGIV3I Grifols 10%
IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days.
Other Name: Intravenous immunoglobulin

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511147

  Show 45 Study Locations
Sponsors and Collaborators
Grifols Biologicals Inc.
Instituto Grifols, S.A.
Investigators
Principal Investigator: Ali Khojasteh, MD Capitol Comprehensive Cancer Care Clinic
  More Information

Responsible Party: Grifols Biologicals Inc.
ClinicalTrials.gov Identifier: NCT00511147     History of Changes
Other Study ID Numbers: IG0601
Study First Received: August 1, 2007
Results First Received: March 3, 2017
Last Updated: May 8, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grifols Biologicals Inc.:
IVIG
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017