Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

Genzyme

Status and phase

Terminated

Phase 1

Conditions

Idiopathic Thrombocytopenic Purpura

Treatments

Biological: GMA161

Study type

Interventional

Funder types

Industry

Identifiers

NCT00244257

GMA16100104

Details and patient eligibility

About

This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to provide written informed consent prior to any study-related procedures
Chronic idiopathic thrombocytopenic purpura diagnosed for at least 6 months
A platelet count of < 100,000/mm^3 on 2 determinations at least 6 weeks apart, including 1 determination within 7 days prior to initiating study treatment. Patients on a stable dose of corticosteroids for 2 weeks prior to study entry and with a platelet count of < 100,000/mm^3 may be enrolled
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, with a life expectancy of at least 6 months

Exclusion criteria

Women who are pregnant or lactating
Women of childbearing potential unless using a medically acceptable contraceptive precaution with the use of spermicide or are sexually inactive
Women who plan to become pregnant within 6 months after the screening phase
Evidence of excessive bleeding requiring hospitalization within 6 weeks of study entry or a red cell transfusion within 6 weeks of study entry
Absolute neutrophil count < 2,000/mm^3
Total bilirubin > 2 mg/dL or alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of normal ranges in the institutional laboratory
Creatinine > 2 mg/dL
History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection
Elevated (≥ 1.5 times the upper limit of normal range) prothrombin time (PT) or partial thromboplastin time (PTT) (other than related to a lupus anticoagulant or contact factor defect)
Evidence of active bacterial infection or viral infection
Active hemolysis that requires red cell transfusion within 6 weeks of study entry (Patients with evidence of concurrent autoimmune hemolysis [Evan's Syndrome] will be allowed)
History of clinically significant cardiac or pulmonary disease
History of cancer, other than: basal cell skin cancer, squamous cell skin cancer with no previous chemotherapy treatment or disease-free carcinoma in situ of the cervix, for a minimum of 5 years from the time of Screening
HIV infection or acute or persistent hepatitis B and C viral infection (characterized by positive hepatitis B surface antigen (HBsAg), positive anti-hepatitis C virus [HCV] or polymerase chain reaction [PCR] assays for HCV)
History of concurrent autoimmune disorders requiring systemic treatment for involvement of organ systems other than cytopenias or thyroid disease
Treatment with cyclophosphamide, vincristine, rituximab, or any other monoclonal antibody within 12 weeks of study infusion
Treatment with intravenous immunoglobulin (IVIg) within 2 weeks of study drug infusion or Rh(D) immune globulin intravenous within 4 weeks of study drug infusion
Treatment with an agent, other than IVIg or corticosteroids, for ITP within 4 weeks of study entry. The dose level of corticosteroids may not be increased or decreased within 2 weeks of study entry
Use of any investigational drug within 12 weeks before Screening
Other pathology that might interfere with the assessment of the safety or efficacy of the test article or other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
Patients who have been splenectomized within 2 months of study entry.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 5 patient groups

Experimental group

Description:

Cohort 1

Treatment:

Biological: GMA161

Experimental group

Description:

Cohort 2

Treatment:

Biological: GMA161

Experimental group

Description:

Cohort 3

Treatment:

Biological: GMA161

Experimental group

Description:

Cohort 4

Treatment:

Biological: GMA161

Experimental group

Description:

Cohort 5

Treatment:

Biological: GMA161

Trial contacts and locations

Data sourced from clinicaltrials.gov

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