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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT02859909
Date of registration: 25/07/2016
Prospective Registration: Yes
Primary sponsor: Biotest
Public title: This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
Scientific 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)
Date of first enrolment: November 2016
Target sample size: 34
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Bulgaria Czechia Germany Hungary Serbia Spain
Name:     Judit Demeter, MD, PhD, DSc
Affiliation:  Semmelweis University Medical School, First Department of Medicine, Department of Hematology, 1083 Budapest, Korányi S. u. 2/a, Hungary
Key inclusion & exclusion 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

- 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

- 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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Immune Thrombocytopenia
Biological: BT595
Primary Outcome(s)
Rate of subjects with response (R) [Time Frame: 1 month]
Secondary Outcome(s)
Duration of response (R), [Time Frame: 1 month]
Occurrence of bleeding symptoms [Time Frame: 1 month]
Subject's maximum platelet count achieved [Time Frame: 1 month]
The number of subjects with a loss of response [Time Frame: 1 month]
The number of subjects with complete response (CR) [Time Frame: 1 month]
The number of subjects with no response (NR) [Time Frame: 1 month]
The number of subjects with response to =50×10^9/L [Time Frame: 1 month]
The percentage of subjects with a loss of response [Time Frame: 1 month]
The percentage of subjects with complete response (CR) [Time Frame: 1 month]
The percentage of subjects with no response (NR) [Time Frame: 1 month]
The percentage of subjects with response to =50×10^9/L [Time Frame: 1 month]
Time course of platelet count [Time Frame: 1 month]
Time to Response (R) [Time Frame: 1 month]
Time to subject's maximum platelet count [Time Frame: 1 month]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Syneos Health
Ethics review
Results available:
Date Posted:
Date Completed:
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