IGIV Study for Chronic ITP Patients Ages 3-70

May 8, 2017 updated by: Grifols Biologicals, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2H7
        • University of Alberta
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • St. Joseph's Healthcare
  • India
      • Ahmedabad, India, 380015
        • Shalby Hospitals
      • Bangalore, India, 560034
        • St. John's Medical College Hospital
      • Haryana, India, 122001
        • Artemis Health Institute
      • Kolkata, India, 700 016
        • Netaji Subhash Chandra Bose Cancer Research Institute
      • Ludhiana, India, 141008
        • Christian Medical College
      • Maharashtra, India, 431001
        • Kodlikeri Hospital
      • Pune, India, 411001
        • Grant Medical Foundation, Ruby Hall Clinic
      • Pune, India, 411004
        • Sahyadri Specialty Hospital
      • Surat, India, 395002
        • Apple Hospital
      • Vellore, India, 632004
        • Christian Medical College
    • Bangalore
      • Karnataka, Bangalore, India, 560099
        • Narayana Hrudayalaya Hospitals
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85061
        • Phoenix Children's Hospital
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Medical Specialists
      • Tucson, Arizona, United States, 85745
        • Arizona Oncology Associates
    • California
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute, LLC
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
      • Southington, Connecticut, United States, 06489
        • Cancer Center of Central Connecticut
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University
      • Washington, D.C., District of Columbia, United States, 20422
        • VA Medical Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Halifax Health Medical Center
      • Lake Worth, Florida, United States, 33461
        • Hematology Oncology Associates
      • Tampa, Florida, United States, 33607-6307
        • Lakeland Regional Cancer Center
      • Tampa, Florida, United States, 33607-6307
        • St. Joseph's Children's Hospital of Tampa
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine Winship Cancer Center
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Hope Children's Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Hematology & Oncology
      • Lansing, Michigan, United States, 48910
        • CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capital Comprehensive Cancer Care Clinic
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ-RWJ Medical School
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Children's Hospital, University of Oklahoma
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvannia Hospital
    • Texas
      • Beaumont, Texas, United States, 77705
        • Baptist Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Tyler, Texas, United States, 75701
        • Tyler Hematology Oncology PA
    • Virginia
      • Richmond, Virginia, United States, 23298
        • MCV Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Intravenous immunoglobulin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days
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.
30 days
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.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grifols Biologicals, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Grifols, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Khojasteh, MD, Capitol Comprehensive Cancer Care Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IG0601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Thrombocytopenic Purpura

Clinical Trials on IGIV3I Grifols 10%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings