Immune Thrombocytopenia Clinical Trial
Official title:
Safety and Efficacy of Eltrombopag at Escalated Doses up to 150mg in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) Not Responsive to 75 mg
Verified date | May 2019 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP
there are some patients who have been reported as non responders at the maximal approved dose
of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and
increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously
published data has shown no overt increase in toxicity in normal volunteers, oncology
patients and aplastic anemia patients treated with escalated doses as high or higher than
those proposed in this study.
It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily,
eltrombopag could be more effective at a higher dose. We propose a double blind randomized
controlled trial in ITP patients who have been defined as non-responders at the maximum dose
(75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg,
150 mg)
Status | Completed |
Enrollment | 35 |
Est. completion date | October 16, 2017 |
Est. primary completion date | February 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - Subject or their parent/ guardian has signed and dated a written informed consent - Male and Females aged 12 years or older diagnosed with chronic ITP according to the new consensus guidelines - No indication of a disease which may cause thrombocytopenia other than ITP----no specific testing required - Subjects with thrombocytopenia = 50,000 /uL after at least 21 days of daily dosage with eltrombopag 75mg - Stable dosage of concomitant treatments for ITP = 2 weeks or longer (corticosteroids); - At least 2 weeks from rescue therapy for ITP (WinRho, Intravenous Immunoglobulin (IVIG), corticosteroids, platelet transfusion) - At least 4 weeks from rituximab treatment - Pregnant or Lactating Women are excluded - Women of child-bearing age with a negative pregnancy test within 7 days of enrollment and who agree to use acceptable methods of birth control will be eligible for this study - Female subjects or female partners of male subjects must either be of non-child bearing potential (hysterectomy, bilateral ovariectomy, bilateral tubal ligation or post menopausal for more than one year) OR, if of child bearing potential, using one of the following highly effective methods of contraception. - complete abstinence from intercourse - Intrauterine device (IUD) - Two forms of barrier contraception. diaphragm plus spermicide, or for males condoms plus spermicide. - Male partner is sterile and is the only partner of the female. - Systemic contraceptives (combined oral progesterone only) Exclusion Criteria: - Previous history of eltrombopag-related liver function test (LFT) elevation that required interruption of treatment - Previous history of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag - HIV Infection - History of Arterial of Venous Thrombosis within the past year or requiring ongoing therapy - Active Hepatitis C infection - Treatment with medications that affect platelet function ( including but not limited to Aspirin, Clopidogrel and /or NSAIDs) or anti-coagulant medications - Elevated Aspartate Aminotransferase(AST/ALT) or Creatinine > 1.5 times upper limit of normal in 4 weeks prior to enrollment* - Abnormalities in white blood cell count (WBC), automatic neutrophil count (ANC), and Hemoglobin > 1.5 times upper or lower limit of normal* - * Subjects can be rescreened to be included |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Responding to >75mg Daily as Defined by a Rise in Platelet Count by 20,000/Microliter, With a Total Platelet Count >50,000/Microliter, ON TWO CONSECUTIVE OCCASIONS During the 8 Week Period | To determine if patients with chronic ITP who do not respond to 75 mg of eltrombopag daily given for at least 3 weeks but then do respond to eltrombopag given daily first for 2 weeks at doses of 100, then for 2 weeks at 125 mg and finally for 4 weeks at a dose of 150mg daily. Response will be defined as 2 consecutive platelet counts of > 50,000 with an increase of > 20,000 from the study baseline within the 8 week increased dose window not as a result of rescue treatment. | 8 weeks | |
Secondary | Number of Particiapants With Drug Related Adverse Events | Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
Completed |
NCT02556814 -
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
|
Phase 4 | |
Terminated |
NCT02401061 -
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
|
Phase 1/Phase 2 | |
Completed |
NCT02351622 -
Caffeic Acid Tablets as a Second-line Therapy for ITP
|
Phase 3 | |
Active, not recruiting |
NCT04741139 -
Post IVIG Medication in Children With Immune Thrombocytopenia
|
Phase 1 | |
Not yet recruiting |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Not yet recruiting |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
Recruiting |
NCT04993885 -
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
|
Phase 2 | |
Recruiting |
NCT05281068 -
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Not yet recruiting |
NCT05020288 -
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
|
Phase 2 | |
Withdrawn |
NCT03965624 -
Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia
|
Phase 2 | |
Not yet recruiting |
NCT03252457 -
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
|
Phase 3 | |
Recruiting |
NCT05937828 -
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
|
||
Completed |
NCT03156452 -
Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate
|
Phase 3 | |
Completed |
NCT03164915 -
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
|
Phase 3 | |
Recruiting |
NCT02270801 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
|
Phase 3 | |
Completed |
NCT01933035 -
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
|
N/A | |
Withdrawn |
NCT01976195 -
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
|
Phase 2 | |
Recruiting |
NCT02821572 -
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
|