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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.
Register: ClinicalTrials.gov
Last refreshed on: 18 March 2024
Main ID:  NCT05220878
Date of registration: 21/01/2022
Prospective Registration: No
Primary sponsor: AO GENERIUM
Public title: Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
Scientific title: Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
Date of first enrolment: September 9, 2021
Target sample size: 160
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT05220878
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Russian Federation
Contacts
Name:     Oksana A. Markova, MD, MSc
Address: 
Telephone:
Email:
Affiliation:  AO GENERIUM
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written Informed Consent Form to participate in the study;

2. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent
Form;

3. Documented diagnosis of ITP with a disease duration of more than 12 months from the
moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results;

4. A. For patients who have not had splenectomy:

- established absence/loss of response to therapy with at least one drug of
fist-line treatment for ITP (which include GCs an IVIG); OR

- the occurrence of side effects during the course of therapy with the drug of the
fist-line, making it impossible to use it further;

B. For patients who underwent splenectomy:

• loss/lack of response to splenectomy;

5. Thrombocytopenia =30.0 x 109/L - <50.0 x 109/L with severe hemorrhagic syndrome or
thrombocytopenia <30.0 x 109/l, regardless of the presence of hemorrhagic syndrome,
according to the results of platelet count conducted in a local laboratory for 7 days
before the start of therapy with investigational or reference drug;

6. Patients receiving GCs, azathioprine and danazole should receive these drugs in a
maintenance dose for at least 4 weeks before starting therapy with investigational or
reference drug;

7. Consent of study participants with preserved childbearing function to use reliable
methods of contraception (a combination of at least two methods, including 1 barrier
method, for example, the use of a condom and spermicide) from the moment of signing
the Informed Consent Form and 3 months after the last administration of
investigational or reference drug.

Exclusion Criteria:

1. Hypersensitivity to the components of investigational or reference drug or E. coli
proteins ;

2. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of
initiation of study or reference drug therapy ;

3. Fisher-Evans Syndrome;

4. Conditions with a high risk of thromboembolic complications ;

5. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;

6. Deviations of clinical and laboratory parameters according to the results of studies
of blood samples taken during the screening period;

7. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
(HIV);

8. Pregnancy or breastfeeding;

9. Use of drugs:

- romiplostim used less than 3 weeks before treatment with study or reference drug;

- IVIG - less than 2 weeks prior to initiation of study or reference drug therapy;

- eltrombopag - used less than 2 weeks before treatment with study or reference
drug, or planned to use eltrombopag while the patient is participating in this
study;

- rituximab - used less than 14 weeks before treatment with study or reference
drug, or planned to use rituximab while the patient is enrolled in this study;

- cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to
treat ITP not listed above and not included in the list of drugs approved for use
during the study - use less than 8 weeks before the start of therapy with the
study or reference drug or the use of any of these drugs is planned during the
patient's participation in this study;

- preparations of any hematopoietic growth factors - use less than 8 weeks before
the start of therapy with an investigational or reference drug;

- Influenza vaccines - less than 21 days prior to start of treatment with study or
reference drug;

- vaccines to prevent novel coronavirus disease (COVID-19) - completion of the
vaccination program less than 21 days prior to the start of study or reference
drug therapy;

- other vaccines - less than 8 weeks prior to start of treatment with study or
reference drug;

10. Splenectomy within 12 weeks prior to screening;

11. Participation in any clinical trials and/or use of unregistered drugs within 4 weeks
prior to screening or 5 drug half-lives (whichever is greater);

12. Any other disease or condition that, in the opinion of the investigator, may preclude
the patient from participating in the study.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Thrombocytopenic Purpura
Intervention(s)
Biological: GNR-069
Biological: Nplate
Primary Outcome(s)
Proportion of patients achieving sustained response to treatment [Time Frame: 26 weeks]
Secondary Outcome(s)
Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count [Time Frame: 26 weeks]
Proportion of patients with no/loss of response to treatment with investigational or reference drug [Time Frame: 26 weeks]
Number of cases of emergency therapy for severe hemorrhagic syndrome during the treatment period, starting from the second week of therapy with the investigational or reference drug [Time Frame: 25 weeks]
Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization [Time Frame: 26 weeks]
Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug [Time Frame: 26 weeks]
Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening [Time Frame: 26 weeks]
Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug [Time Frame: 26 weeks]
Secondary ID(s)
RMP-ITP-III
? 407 eff. date 29 July 2021
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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