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Completed Phase 3 Interventional Results available

A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

ClinicalTrials.gov ID: NCT00504075

Public ClinicalTrials.gov record NCT00504075. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response \>60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

Study identification

NCT ID
NCT00504075
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bio Products Laboratory
Other
Enrollment
35 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2007 (Type not available)
Primary completion
Aug 2011 (Actual)
Completion
Aug 2011 (Actual)
Last update posted
Mar 1, 2013

2007 – 2011

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Mid Florida Hematology & Oncology Orange City Florida 32763 —
Rush University Medical Center Chicago Illinois 60612 —
Center for Cancer & Blood Disorders Bethesda Maryland 20817 —
New York Hospital / Cornell University, Division of Pediatrics New York New York 10021 —
Department of Pediatrics, SUNY at Stony Brook Stony Brook New York 11794-8111 —
Oregon Health & Science University Portland Oregon 97239 —
Cancer Care Centers of South Texas San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00504075, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 1, 2013 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00504075 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →