End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | June 2011 |
End of EXTEND: Observing for Sustained Response Despite Discontinuation of Medication in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) Treated With Eltrombopag
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).
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).
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
- 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 ovariectomy, bilateral tubal
ligation or post menopausal 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. atrial 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.
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