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Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT02298075
Recruitment Status : Unknown
Verified October 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : November 21, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:
The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who failed one or more therapy lines, splenectomy included.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Drug: Eltrombopag Drug: Romiplostin

Detailed Description:
Increasing evidence exists in the literature on the persistent response after TPO-RAs discontinuation. However, the available data consist of description of case reports from different patients' series. At this time, systematic data collections on this topic do not exist and the real incidence of such persistent response is unknown. Therefore, because of the increasing interest in this new and challenging therapeutic field, also for the therapeutic implications, we would like to investigate the impact of TPO- RAs on the achievement of sustained and persistent responses after their discontinuation in the Italian adult patients affected by pITP who have been referred to the GIMEMA Centers.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Response Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective Study
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Eltrombopag
    Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
    Other Name: Thrombopoietin Receptor Agonists (TPO-RAs)
  • Drug: Romiplostin
    Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
    Other Name: Thrombopoietin Receptor Agonists (TPO-RAs)

Outcome Measures
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Primary Outcome Measures :
  1. Estimation of sustained response rate after discontinuation of treatment with TPO-RAs in terms of patients still alive in Complete Response or R at more than 4 weeks after discontinuation. [ Time Frame: One year from start of recruitment. ]

Secondary Outcome Measures :
  1. Frequency of the type of response in patients treated with TPO-RAs in absence of concomitant or rescue medication, in order to estimate the rate of Response (R) and Complete Response (CR). [ Time Frame: One year from start of recruitment. ]
  2. Estimation of the suspension criteria in terms of frequency of discontinuation causes for each center. [ Time Frame: One year from start of recruitment. ]
  3. Estimation of the duration of sustained response in terms of patients alive in CR or R at 6 and 12 months after sustained response achievement. [ Time Frame: One year from start of recruitment. ]
  4. Estimation of incidence of relapse and loss of response at 6 and 12 months after sustained response achievement. [ Time Frame: One year from start of recruitment. ]
  5. Estimation of treatment duration starting from the date of first dose of TPO-RAs. [ Time Frame: One year from start of recruitment. ]
  6. Description of Platelet levels and TPO-RAs dosage at stop. [ Time Frame: One year from start of recruitment. ]
  7. Description of patients' characteristics in term of: biological and clinical features, disease duration at the beginning of TPO-RAs, number and type of therapy lines preceding TPO-RAs treatment, platelet levels at TPO-RAs start. [ Time Frame: One year from start of recruitment. ]
  8. Assessment of an association between previous splenectomy and sustained response after discontinuation of treatment with TPO-RAs. [ Time Frame: One year from start of recruitment. ]
  9. Description of concomitant therapies since TPO-RAs start in terms of type and duration of therapies. [ Time Frame: One year from start of recruitment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by primary immune thrombocytopenia (pITP)
Criteria

Inclusion Criteria:

  • Signed written informed consent according to ICH/EU/GCP and national local laws;
  • Persistent or chronic pITP adult patients who have been treated with TPO-RAs therapy after failure of one or more therapy lines, splenectomy included;
  • Age > 18 years.

Exclusion Criteria:

  • Active malignancy;
  • Active malignancy;
  • HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
  • Chronic liver disease;
  • Treatment with Rituximab less than 8 weeks before TPO-RAs start;
  • Recent splenectomy (less than 8 weeks) before TPO-RAs start. Active malignancy;
  • HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
  • Chronic liver disease;
  • Treatment with Rituximab less than 8 weeks before TPO-RAs start;
  • Recent splenectomy (less than 8 weeks) before TPO-RAs start. HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
  • Chronic liver disease;
  • Treatment with Rituximab less than 8 weeks before TPO-RAs start;
  • Recent splenectomy (less than 8 weeks) before TPO-RAs start.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298075


Contacts
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Contact: Enrico Crea e.crea@gimema.it
Contact: Paola Fazi p.fazi@gimema.it

Locations
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Italy
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti Recruiting
Asti, Italy
Contact: Monia Marchetti         
Principal Investigator: Monia Marchetti         
Istituto di Ematologia "Lorenzo e A. Seragnoli" Recruiting
Bologna, Italy
Contact: Nicola Vianelli         
Principal Investigator: Nicola Vianelli         
Sub-Investigator: Francesca Palandrini         
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi Not yet recruiting
Catania, Italy
Contact: Ugo Consoli         
Principal Investigator: Ugo Consoli         
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano Recruiting
Firenze, Italy
Contact: Alberto Bosi         
Principal Investigator: Alberto Bosi         
Clinica Medica III - Padiglione ex isolamento - Azienda Ospedale Università San Martino Recruiting
Genova, Italy
Contact: Enrico Balleari         
Principal Investigator: Enrico Balleari         
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Recruiting
Lecce, Italy
Contact: Nicola Di Renzo         
Principal Investigator: Nicola Di Renzo         
Sub-Investigator: Margherita Giannoccaro         
Azienda Ospedaliera "S.Gerardo" Recruiting
Monza, Italy
Contact: Monia Carpenedo         
Principal Investigator: Monia Carpenedo         
Ematologia - Ospedale San Carlo Recruiting
Potenza, Italy
Contact: Angela Amendola         
Principal Investigator: Angela Amendola         
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Elena Rivolti         
Principal Investigator: Elena Rivolti         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Valerio De Stefano         
Principal Investigator: Valerio De Stefano         
Sub-Investigator: Elena Rossi         
U.O.C. Ematologia - Ospedale S. Eugenio Recruiting
Rome, Italy
Contact: Laura Scaramucci         
Principal Investigator: Laura Scaramucci         
Sub-Investigator: Pasquale Niscola         
Università degli studi "Sapienza" di Roma Recruiting
Rome, Italy
Contact: Maria Gabriella Mazzucconi         
Ematologia - Dipartimento di Medicina Clinica e Sperimentale Recruiting
Sassari, Italy
Contact: Claudio Fozza         
Principal Investigator: Claudio Fozza         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Maria Gabriella Mazzucconi Policlinico Umberto I, Hematology Department.
More Information
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Additional Information:

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02298075    
Other Study ID Numbers: ITP0714
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Immune thrombocytopenia
Primary
Thrombopoietin receptor agonist
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
 Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations