Study Complete

Sponsor ID

20080009

Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated with immune thrombocytopenia purpura (ITP)

Sponsor ID

20080009

Clinicaltrials.gov ID

NCT00907478

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

The purpose of this study is to evaluate changes in bone marrow morphology (structure) after long-term exposure to romiplostim.

Additional Study Details

Phase

Phase 4

Product

romiplostim

Type

Interventional

Masking

None (Open Label)

Enrollment

169

Additional Study Details

Protocol Summary

Primary Outcome Measures

The incidence of collagen fibrosis as evidenced by trichrome staining

Timeframe: At Years 1, 2 or 3 after initial exposure of romiplostim

Secondary Outcome Measures

The incidence of clinically relevant changes in QT/QTc intervals, as defined as an absolute QTc interval > 500 ms or a QTc interval increase from baseline ≥ 60 ms post romiplostim exposure

Timeframe: from Week 3 through End of Study (maximum total time is approximately 3 years + 3 months)

The incidence of any improvement of reticulin to a grade of ≤ 2 for subjects who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale

Timeframe: At Year 1, Year 2, or Year 3 post romiplostim exposure

The incidence of CTCAE grade ≥ 2 shift in anemia or neutropenia post romiplostim exposure

Timeframe: from Screening through End of Study (maximum total time estimated to be approximately 3 years + 3 months)

The incidence and severity of all adverse events including clinically significant changes in laboratory values

Timeframe: from Screening through End of Study (maximum total time estimated to be approximately 3 years + 3 months)

The incidence of neutralizing antibody formation to romiplostim or cross-reacting antibodies to endogenous thrombopoietin

Timeframe: from Screening through End of Study (maximum total time estimated to be approximately 3 years + 3 months)

The incidence of collagen fibrosis as evidenced by trichrome staining in subjects who developed collagen fibrosis at Yrs 1, 2, or 3 after initial exposure of romiplostim using modified Bauermeister grading scale

Timeframe: 12 wks after romiplostim discontinuation

The incidence of bone marrow reticulin increases by ≥ 2 severity grades or increase to grade 4 over baseline as evidenced by reticulin silver staining using the modified Bauermeister grading scale

Timeframe: At Year 1, Year 2, or Year 3 post romiplostim exposure

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.

Study Info

Age

18+ years

Condition

Thrombocytopenia

Sex

All

Trial Dates

Aug 2009 - Jan 2014

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Inclusion and Exclusion Criteria

Inclusion Criteria:

- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines - Subject must have had a bone marrow biopsy within one year prior to planned first dose of romiplostim (with available bone marrow tissue block or unstained histological slides to send to a central laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy within 3 weeks prior to planned first dose of romiplostim. Central laboratory interpretation is required prior to first dose of romiplostim - Subject must agree to a scheduled bone marrow biopsy at Year 1, Year 2, or Year 3 following romiplostim treatment and any unscheduled biopsies if clinically indicated - Subject ≥18 years of age - Baseline bone marrow reticulin grade of 0, 1, 2, or 3 according to the modified Bauermeister grading scheme as assessed by central laboratory interpretation - Platelet count < 50 x 10^9/L - Must have received at least 1 prior ITP therapy (examples of ITP therapy include corticosteroids, intravenous immunoglobulin [IVIG], splenectomy) - Subject (or legally-acceptable representative) is willing and able to provide written informed consent

Exclusion Criteria:

- Baseline bone marrow biopsy positive for collagen fibrosis - Any known history of or currently active bone marrow stem cell disorder, hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome - Any current active malignancy - Any prior exposure to cytostatic chemotherapy or radiotherapy for malignancy - Subject has undergone pacemaker placement, cardiac ablation of arrhythmia, and/or any current treatment with Vaughan Williams Class IA – IC and Class III agents (Vaughan Williams, 1970) - Subject has participated in any study evaluating pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), or thrombopoietin receptor agonists (ie romiplostim or eltrombopag) - Subject has a known hypersensitivity to any recombinant E coli-derived product - Subject is currently enrolled in or has not yet completed (at least 4 weeks since ending) other investigational device or drug trial(s) or subject is receiving other investigational agent(s) - Other investigational procedures are excluded - Subject of child-bearing potential is evidently pregnant (eg positive pregnancy test) or is breast feeding - Subject is not using adequate contraceptive precautions - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative and/or is unable to comply with study procedures.