"End of EXTEND: Observing for Cure in Patients With Chronic ITP"

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01386723
First received: June 13, 2011
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months. This requires that if patients stop treatment with eltrombopag, they are not immediately transitioned to further treatment unless it is necessary.

The objective of the study is to assess how frequently patients who have discontinued eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8 weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).


Condition Intervention
Purpura, Thrombocytopenic, Idiopathic
Other: Observational study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: "End of EXTEND: Observing for Cure in Patients With Chronic ITP"

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   Samples Without DNA

Blood specimens


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
discontinuation of eltrombopag
ITP subjects who have discontinued the use of eltrombopag
Other: Observational study
Observation of subjects as they discontinue the use of eltrombopag
Other Name: eltrombopag, promacta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ITP patients discontinuing the use of eltrombopag

Criteria

Inclusion Criteria:

  • A subject is eligible for study entry if all of the following criteria apply:

    • Subject or their guardian has signed and dated a written informed consent
    • Male or female adults (≥ 18 years) diagnosed with ITP according to the new consensus guidelines (Provan, Blood, 2009].
    • No indication of a disease which may cause thrombocytopenia other than ITP.
    • Having taken eltrombopag for at least 4 months prior to beginning of study.
    • Subject experienced no toxicity other than transient eltrombopag-related toxicity or other drug intolerance.
    • Subjects treated with concomitant ITP medications (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least four weeks prior to start of this study.
    • A subject is practicing an acceptable method of contraception (documented in chart). female subjects or female partners of male subjects must either be of non-child bearing potential (hysterectomy, bilateral ovarectomy, bilateral tubal ligation or post menauposal for more than one year) OR of child bearing potential using one of the following highly effective methods of contraception.
  • complete abstinence from intercourse
  • Intrauterine device (IUD)
  • Two forms of barrier contraception. diaphragm plus spermicide, or for males condoms plus spermicide.
  • Male partner is sterile and is the only partner of the female.
  • Systemic contraceptives (combined oral progesterone only)

Exclusion Criteria:

A subject is at least temporarily ineligible for the study if any of the following criteria apply:

  • Any clinically relevant abnormality, other than chronic ITP, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study such as:

    • an active malignancy
    • an arterial or venous thrombosis
    • development of grade III-IV cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. artrial fibrillation), or subjects with a QTc >480 msec.
  • Recent history of alcohol/drug abuse.
  • Subjects recently treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
  • development of platelet agglutination abnormality that prevents reliable measurement of platelet counts.

Rescreening is possible if the condition resulting in the failed screening has been resolved. There will be no limit on the number of screening tests and the screening will be valid for 30 days.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386723

Locations
United States, New York
Weill Cornell Medical College/New York Presbyterian Hospital Recruiting
NY, New York, United States, 10065
Contact: Nayla Boulad, BA    212-746-4933    nab2015@med.cornell.du   
Contact: Megan Wissert, RN,BSN    2127463416    mwissert@med.cornell.edu   
Principal Investigator: James Bussel, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
GlaxoSmithKline
Investigators
Principal Investigator: James B. Bussel, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01386723     History of Changes
Other Study ID Numbers: 1003010950
Study First Received: June 13, 2011
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014