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TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients. (ITP0614)

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ClinicalTrials.gov Identifier: NCT02063763
Recruitment Status : Recruiting
First Posted : February 14, 2014
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date February 13, 2014
First Posted Date February 14, 2014
Last Update Posted Date August 6, 2018
Study Start Date May 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2014)
Number of patients responding to TPO-mimetics [ Time Frame: Six months. ]
According to platelet count and presence or absence of hemorrhagic events.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2014)
  • Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy. [ Time Frame: Six months. ]
  • Frequency and ways of administration. [ Time Frame: Six months ]
  • Number of hemorrhagic events. [ Time Frame: At thirty days from splenectomy. ]
    Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
  • Frequency of toxicity. [ Time Frame: Six months ]
    NCI CTCAE v. 4.0
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.
Official Title Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
Brief Summary This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.
Detailed Description

Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. Its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults.

Splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a long term response (around 60+70%). Nevertheless, splenectomy may be accompanied by peri-operative complications in almost 10% of patients, which in rare cases may be fatal. These are normally hemorrhagic complications due to low platelet count. Thus, a previous therapy to increase platelets is advisable before any splenectomy.

In patients who are refractory to corticosteroids and immunoglobulins or when its use is not indicated, splenectomy has a potential risk of more complications. Since the last few years, we count with TPO-mimetic drugs, specific for c-MPL receptor, able to stimulate platelet production, such as romiplostim and eltrombopag.

Nowadays, TPO-mimetics are allowed in Italy when patients refuse splenectomy or when splenectomy is not contraindicated, but being ITP with a low platelet count (< 20-50.000/mmc) a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be considered. Nevertheless, there are no data on therapeutic risks and safety of these agents when used for this indication. The aim of the present study is to verify, on an Italian national scale, the frequency of use, its impact and the safety profile.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.
Condition
  • Adult Patients
  • Immune Primary Thrombocytopenia
  • Splenectomy
  • TPO-mimetics
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: February 13, 2014)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Persistent or chronic ITP in symtomatic phase.
  • 18 years of age or older.
  • Indication for splenectomy due to refractory response to a previous therapy.
  • Have used eltrombopag or romiplostim to increase platelet count before splenectomy.
  • Have undergone splenectomy.

Exclusion Criteria:

  • No informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Enrico Crea e.crea@gimema.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02063763
Other Study ID Numbers ITP0614
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators Not Provided
Investigators
Study Chair: Francesco Zaja, Pr. Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date August 2018