Study Stopped
Study terminated due to low enrollment.
Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
1 other identifier
interventional
10
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2005
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 9, 2015
April 1, 2015
2.9 years
October 25, 2005
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate safety, tolerability and pharmacokinetics (PK) of single intravenous (IV) infusions of GMA161 in patients with idiopathic thrombocytopenic purpura (ITP)
up to 3 years
Study Arms (5)
1
EXPERIMENTALCohort 1
2
EXPERIMENTALCohort 2
3
EXPERIMENTALCohort 3
4
EXPERIMENTALCohort 4
5
EXPERIMENTALCohort 5
Interventions
0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Bethesda, Maryland, 20892, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2005
First Posted
October 26, 2005
Study Start
August 1, 2005
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 9, 2015
Record last verified: 2015-04