Status:
COMPLETED
An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN
Lead Sponsor:
Biocad
Conditions:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To study the long-term safety and efficacy of BCD-148 in patients with paroxysmal nocturnal hemoglobinuria (PNH), previously treated in clinical study (CS) BCD-148-2/NOCTURN
Detailed Description
The clinical study BCD-148-EXT was an extension of a multicenter, randomized, open-label, comparative study of the efficacy and safety of BCD-148 in PNH patients versus SOLIRIS® (BCD-148-2/NOCTURN). ...
Eligibility Criteria
Inclusion
- Signed IC form for participation in the study.
- Indications for pathogenesis-based therapy of PNH with an anti-C5 monoclonal antibody (eculizumab).
- Consent for revaccination against Neisseria meningitidis .
- Negative pregnancy test for urine human chorionic gonadotropin (HCG) in women at enrollment in study BCD-148-EXT (the test was not performed in women who have been postmenopausal for at least 2 years, or in surgically sterile subjects) .
- Willingness of patients and their sexual partners of childbearing potential to use reliable contraceptive measures from signing the IC form throughout the study and for 4 weeks after the last drug dosing in the clinical study. This requirement did not apply to patients who underwent surgical sterilization and women who have been postmenopausal for over 2 years. Reliable methods of contraception included the use by partners of one barrier method in combination with one of the following: spermicides, intrauterine device, oral contraceptives (for female partners of male subjects only, for female study participants - upon agreement with the Sponsor and with justification by the investigator) .
- The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.
Exclusion
- Patient withdrawal from clinical study BCD-148-2/NOCTURN until its completion for any reason.
- Pregnancy or breastfeeding, or planning of pregnancy by a female participant/planning conceiving a child by a male participant during the clinical study.
- Any conditions that, in the investigator's opinion, could increase the patient's risk associated with participation in the study or could affect the assessment of the study results.
- Hypersensitivity to BCD-148 components, murine proteins, and other components of the products according to the patient's history; hypersensitivity to any component of the meningococcal vaccine.
- Known alcohol or drug addiction, or signs of alcohol/drug addiction, which, according to the investigator, were a contraindication for the treatment with the study drug or limited the treatment compliance.
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06987864
Start Date
April 13 2020
End Date
November 2 2022
Last Update
May 29 2025
Active Locations (11)
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1
Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"
Barnaul, Russia
2
State Autonomous Healthcare Institution "S.V. Belyaev Kuzbass Regional Clinical Hospital"
Kemerovo, Russia
3
Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
Kirov, Russia
4
Moscow State Budgetary Healthcare Institution "S.P. Botkin Municipal Clinical Hospital of the Moscow Healthcare Department"
Moscow, Russia