Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01443351
Other study ID # TPO-SJ-227
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2015
Est. completion date August 2019

Study information

Verified date September 2019
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with ITP

- platelet counts < 25 x10*9/L or < 50 x10*9/L with bleeding symptoms

- meets criteria for treatment with TPO-ra

- Females must use contraceptives when applicable for at least three months before inclusion

Exclusion Criteria:

- Pregnancy or nursing

- Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation

- Liver insufficiency (for eltrombopag only)

- TPO-ra contraindications (e.g. allergy)

- TPO-ra treatments less than 6 months prior to inclusion

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Copenhagen University Hospital Roskilde Roskilde

Sponsors (3)

Lead Sponsor Collaborator
Zealand University Hospital Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with sustained response at 6 months follow-up Response is defined as platelet count > 30.000 mio/L and no bleeding 6 months
Secondary Yearly response rates Number of patients with response to treatment at 1, 2, 3, 4, and 5-year follow-up 5 years
Secondary Frequency of relapse 5 years
Secondary Rate of splenectomy 5 years
Secondary Development of reticulin fibrosis in bone marrow biopsies 5 years
See also
  Status Clinical Trial Phase
Completed NCT05220878 - Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP Phase 3
Completed NCT00451594 - High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP Phase 3
Withdrawn NCT01276561 - Single Incision Versus Standard Laparoscopic Splenectomy N/A
Completed NCT01713855 - Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura N/A
Recruiting NCT03465020 - Investigation on a Dynamic Cohort of Italian Patients With Active ITP
Completed NCT00603642 - P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura Phase 3
Completed NCT01143038 - Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim Phase 2
Not yet recruiting NCT04128358 - Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind? N/A
Completed NCT00128882 - Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D Phase 2
Completed NCT01525836 - rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP Phase 3
Completed NCT00888901 - Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag Phase 4
Completed NCT00828750 - Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 3
Completed NCT00625443 - Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 Phase 2
Completed NCT00475423 - A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. Phase 2
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
Completed NCT00102323 - AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy Phase 3
Completed NCT05492409 - Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients Phase 3
Terminated NCT01433978 - A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) Phase 3
Completed NCT01520909 - Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. Phase 3
Not yet recruiting NCT06287567 - Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP) Phase 4