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Idiopathic Thrombocytopenic PurpuraPhase 1NCT00244257

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

A Phase 1 study testing GMA161 in people with Idiopathic Thrombocytopenic Purpura, run by Genzyme, a Sanofi Company at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Thrombocytopenic Purpura
What is being tested?
GMA161
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesUnited States
Study dates
Aug 2005to Jul 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Bethesda, Maryland, 20892

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Los Angeles, California, 90033

  • Study site

    New York, New York, 10021

  • Study site

    San Diego, California, 92121

Other trials in United States

About this study

Official title: 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)

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.

Being tested
GMA161
Keywords
idiopathic thrombocytopenia purpura
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMA161Biological

    0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

  • GMA161Biological

    0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

  • GMA161Biological

    0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

  • GMA161Biological

    1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

  • GMA161Biological

    3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

Study groups in NCT00244257
Study groupRoleWhat they receive
1ExperimentalCohort 1
Receives: Biological: GMA161
2ExperimentalCohort 2
Receives: Biological: GMA161
3ExperimentalCohort 3
Receives: Biological: GMA161
4ExperimentalCohort 4
Receives: Biological: GMA161
5ExperimentalCohort 5
Receives: Biological: GMA161

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate safety, tolerability and pharmacokinetics (PK) of single intravenous (IV) infusions of GMA161 in patients with idiopathic thrombocytopenic purpura (ITP)

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJul 2008
  4. Study completionJul 2008

Why it stopped: Study terminated due to low enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244257
Sponsor's protocol ID
GMA16100104
Status last verified
Apr 2015
First submitted
25 Oct 2005
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GMA161 in people with Idiopathic Thrombocytopenic Purpura, run by Genzyme, a Sanofi Company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00244257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.

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