NIH Clinical Research Studies

Protocol Number: 05-H-0243

Active Followup, Protocols NOT Recruiting New Patients

Title:
A Phase I, Open-Label, Multiple-Center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetic and Pharmacodynamic Study of GMA161 in Patients with Idiopathic Thrombocytopenic Purpura (ITP)
Number:
05-H-0243
Summary:
This study will: 1) examine whether a new drug called GMA161 is safe when administered to patients with idiopathic thrombocytopenic purpura (ITP); and 2) evaluate how the body handles the drug at different doses. In patients with ITP, platelets (a component of blood needed for clotting) are rapidly destroyed. Patients are at increased risk of bleeding, commonly in the skin (bruising) and mucous membranes (nosebleeds). Bleeding can also occur in the stomach, intestines, kidneys, brain and other organs and lead to serious complications. GMA161 is a monoclonal antibody that may transiently increase platelet counts.

Screening Phase

Patients 18 years of age and older who have been diagnosed with ITP for at least 6 months may be eligible for this study. Each candidate is screened with a medical history, physical examination, chest x-ray, and blood and urine tests.

Drug Administration Phase

Participants who qualify for the study would return to NIH to receive an infusion of GMA161 through a small needle-like tube inserted into a vein in the arm. Additional procedures done on the day of this visit will include a brief physical examination and measurement of vital signs (temperature, heart rate, respiratory rate, blood pressure, oxygen levels) as well as blood samples taken a number of times before and after the infusion. This visit takes 12 to 14 hours and is at NIH.

Follow-up Phase

Participants will return for regular visits for a minimum of 6 weeks. These visits take 1 to 2 hours and may be done at NIH or at home by a nurse and by telephone call from an NIH research nurse. The procedures patients will undergo at these visits may include an update on health status, transfusions record, and medication use since the previous visit; a brief physical examination; measurement of vital signs; and urine and blood sample collection. Patients will also undergo an electrocardiogram once during the follow-up phase.

Please call for more details.

Sponsoring Institute:
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
Monoclonal Antibody Therapy
Recruitment Keyword(s):
Immune Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
ITP
Condition(s):
Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenia
Investigational Drug(s):
Humanized MAbx (GMA161)
Investigational Device(s):
None
Interventions:
Drug: Humanized MAbx (GMA161)
Supporting Site:
National Heart, Lung and Blood Institute

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Harrington WJ, Minnich V, Hollingsworth JW, Moore CV. Demonstration of a thrombocytopenic factor in the blood of patients with thrombocytopenic purpura. 1951. J Lab Clin Med. 1990 May;115(5):636-45. No abstract available.

McMillan R, Tani P, Mason D. The demonstration of antibody binding to platelet-associated antigens in patients with immune thrombocytopenic purpura. Blood. 1980 Dec;56(6):993-5.

Rebulla P, Finazzi G, Marangoni F, Avvisati G, Gugliotta L, Tognoni G, Barbui T, Mandelli F, Sirchia G. The threshold for prophylactic platelet transfusions in adults with acute myeloid leukemia. Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto. N Engl J Med. 1997 Dec 25;337(26):1870-5.

Active Followup, Protocols NOT Recruiting New Patients

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