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This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859909
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Biotest

Brief Summary:
The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Biological: BT595 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP)
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: 2 day treatment schedule
Patients will receive a dosage of 1 g/kg bw per day of BT595 for 2 consecutive days
Biological: BT595
Other Name: Human Immunoglobulin

Experimental: 5 day treatment schedule
Patients will receive a dosage of 0.4 g/kg bw per day of BT595 for 5 consecutive days
Biological: BT595
Other Name: Human Immunoglobulin




Primary Outcome Measures :
  1. Rate of subjects with response (R) [ Time Frame: 1 month ]
    The rate of subjects with response is defined as subjects with a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding


Secondary Outcome Measures :
  1. The number of subjects with complete response (CR) [ Time Frame: 1 month ]
    The number of subjects with CR, which is defined as a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding

  2. The percentage of subjects with complete response (CR) [ Time Frame: 1 month ]
    The percentage of subjects with CR, which is defined as a platelet count ≥100×10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding

  3. The number of subjects with no response (NR) [ Time Frame: 1 month ]
    The number of subjects with NR, which is defined as subjects without R, i.e. a platelet count <30×10^9/L or less than a 2 fold increase of baseline platelet count, confirmed on at least 2 separate occasions, approximately 1 day apart, or bleeding

  4. The percentage of subjects with no response (NR) [ Time Frame: 1 month ]
    The percentage of subjects with NR, which is defined as subjects without R, i.e. a platelet count <30×10^9/L or less than a 2 fold increase of baseline platelet count, confirmed on at least 2 separate occasions, approximately 1 day apart, or bleeding

  5. The number of subjects with a loss of response [ Time Frame: 1 month ]
    The number of subjects with a loss of response (only in subjects who previously had CR or R), which is defined as a platelet count <100×10^9/L or bleeding (from CR) or platelet count <30×10^9/L or less than 2 fold increase of the baseline platelet count, or bleeding (from R). Platelet counts will be confirmed on at least 2 separate occasions approximately 1 day apart

  6. The percentage of subjects with a loss of response [ Time Frame: 1 month ]
    The percentage of subjects with a loss of response (only in subjects who previously had CR or R), which is defined as a platelet count <100×10^9/L or bleeding (from CR) or platelet count <30×10^9/L or less than 2 fold increase of the baseline platelet count, or bleeding (from R). Platelet counts will be confirmed on at least 2 separate occasions approximately 1 day apart

  7. Time to Response (R) [ Time Frame: 1 month ]
    Time to response (R), which is defined as the time from the start of treatment to the time of achievement of CR or R

  8. Duration of response (R), [ Time Frame: 1 month ]
    Duration of response (R), which is defined as the time from the achievement of CR or R to loss of CR or R

  9. The number of subjects with response to ≥50×10^9/L [ Time Frame: 1 month ]
    The number of subjects with response to ≥50×10^9/L, which is defined as a platelet count increase to at least ≥50×10^9/L within 7 days of the first BT595 infusion

  10. The percentage of subjects with response to ≥50×10^9/L [ Time Frame: 1 month ]
    The percentage of subjects with response to ≥50×10^9/L, which is defined as a platelet count increase to at least ≥50×10^9/L within 7 days of the first BT595 infusion

  11. Subject's maximum platelet count achieved [ Time Frame: 1 month ]
  12. Time to subject's maximum platelet count [ Time Frame: 1 month ]
  13. Time course of platelet count [ Time Frame: 1 month ]
  14. Occurrence of bleeding symptoms [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Diagnosis of chronic ITP (>12 months' duration), including diagnosis of refractory ITP, and as defined by the International Working Group (Rodeghiero et al, 2009), where ITP is described as an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes or disorders that may be associated with thrombocytopenia
  • Treatment is indicated because of a high risk of bleeding or a need to raise the platelet count
  • Mean screening platelet count of <30×10^9/L from 3 qualifying platelet counts performed within approximately 7 to 14 days before the start of treatment, with no individual platelet count above 35×10^9/L. The subject may be rescreened if the mean screening platelet count is ≥30×10^9/L. (Note: If a subject is rescreened, all screening laboratory tests must be repeated.)

Main Exclusion Criteria:

  • Secondary thrombocytopenia or acquired medical conditions known to be associated with secondary thrombocytopenia, such as chronic lymphocytic leukemia; lymphoma; multiple myeloma; thyroid disease; or other forms of thrombocytopenia, such as drug induced thrombocytopenia; cirrhotic liver diseases; antiphospholipid syndrome; environmental thrombocytopenia; and bone marrow diseases
  • Severe concomitant diseases that in the judgment of the investigator will interfere with the study, such as autoimmune hemolytic anemia, acute renal failure, and noncontrolled arterial hypertension
  • Laboratory findings (e.g., abnormal laboratory values for hemoglobin, transaminase levels [alanine aminotransferase, aspartate aminotransferase], total bilirubin, creatinine, blood urea nitrogen, and immunoglobulins G, A, M) that preclude participation
  • Positive Coombs test (direct and indirect)
  • Planned invasive procedures during the time frame of the study
  • Maintenance therapy with intravenous immunoglobulins (IVIgs) or infusion of IVIgs within 3 months before start of the study
  • Unresponsive to previous IVIg treatment
  • Additional therapy with high dose corticosteroids (equivalent to >30 mg prednisone/day), thrombopoietin receptor agonists, and/or immunosuppressives and/or other therapies (e.g., infusion of platelets) within 1 month before the start of the study (Note: Subjects on stable doses of ITP active treatment must not have modified the dose in the preceding 2 weeks and must maintain their prestudy dose during the study. Corticosteroids should not be given as a premedication. Rescue therapy with short courses [i.e., 1 to 4 days] of high dose steroids and IVIgs are allowed up to 2 weeks before study inclusion.)
  • History of thrombotic events (including myocardial infarction, cerebral vascular accident [including stroke], pulmonary embolism, and deep vein thrombosis) 6 months before treatment start with BT595 or the presence of significant risk factors for thrombotic events
  • Therapy with live attenuated virus vaccines 3 months before start of the study
  • Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA

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): NCT02859909


Locations
Show Show 22 study locations
Sponsors and Collaborators
Biotest
Syneos Health
Investigators
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Principal Investigator: Judit Demeter, MD, PhD, DSc Semmelweis University Medical School, First Department of Medicine, Department of Hematology, 1083 Budapest, Korányi S. u. 2/a, Hungary
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Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT02859909    
Other Study ID Numbers: 992
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Signs and Symptoms
Immunoglobulins
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs