Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 69 for:    Recruiting, Not yet recruiting Studies | Immune Thrombocytopenia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02298075
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date November 17, 2014
First Posted Date November 21, 2014
Last Update Posted Date October 23, 2018
Study Start Date April 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2014)
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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 19, 2014)
  • 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. ]
  • Estimation of the suspension criteria in terms of frequency of discontinuation causes for each center. [ Time Frame: One year from start of recruitment. ]
  • 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. ]
  • 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. ]
  • Estimation of treatment duration starting from the date of first dose of TPO-RAs. [ Time Frame: One year from start of recruitment. ]
  • Description of Platelet levels and TPO-RAs dosage at stop. [ Time Frame: One year from start of recruitment. ]
  • 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. ]
  • 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. ]
  • Description of concomitant therapies since TPO-RAs start in terms of type and duration of therapies. [ Time Frame: One year from start of recruitment. ]
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 Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia
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
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients affected by primary immune thrombocytopenia (pITP)
Condition Immune Thrombocytopenia
Intervention
  • 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)
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: November 19, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
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
Contact: Paola Fazi p.fazi@gimema.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02298075
Other Study ID Numbers ITP0714
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: Maria Gabriella Mazzucconi Policlinico Umberto I, Hematology Department.
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date October 2018