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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00244257
Recruitment Status : Terminated (Study terminated due to low enrollment.)
First Posted : October 26, 2005
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 26, 2005
Last Update Posted Date April 9, 2015
Study Start Date  ICMJE August 2005
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Evaluate safety, tolerability and pharmacokinetics (PK) of single intravenous (IV) infusions of GMA161 in patients with idiopathic thrombocytopenic purpura (ITP) [ Time Frame: up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
Evaluate safety, tolerability and PK if single IV infusions of GMA161 in patients with ITP
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Thrombocytopenic Purpura
Intervention  ICMJE
  • Biological: GMA161
    0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
  • Biological: GMA161
    0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
  • Biological: GMA161
    0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
  • Biological: GMA161
    1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
  • Biological: GMA161
    3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples
Study Arms  ICMJE
  • Experimental: 1
    Cohort 1
    Intervention: Biological: GMA161
  • Experimental: 2
    Cohort 2
    Intervention: Biological: GMA161
  • Experimental: 3
    Cohort 3
    Intervention: Biological: GMA161
  • Experimental: 4
    Cohort 4
    Intervention: Biological: GMA161
  • Experimental: 5
    Cohort 5
    Intervention: Biological: GMA161
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 24, 2008)
10
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244257
Other Study ID Numbers  ICMJE GMA16100104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Genzyme, a Sanofi Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP