A randomized, international, multicenter double-blind study to compare the efficacy,safety, and immunogenicity of PZN-128 powder for solution for subcutaneous injection 250 µg (Pharmasyntez Nord JSC, Russia) versus ?omparator drug in patients with chronic idiopathic (immune) thrombocytopenic purpura. - NI

PHARMASYNTEZ-NORD JSC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1. Informed consent to participate in the study.
•2. Patients of both genders aged from 18 years.
•3. Patients with diagnosed chronic idiopathic (autoimmune) thrombocytopenic purpura resistant to the first-line therapy.
•4. Platelet count at the time of screening = 30 x 10 ? /L.
•5. Patients agreed to use a reliable method of contraception during the study up to its completion (for the subjects with reproductive potential).
•6. Patients, in the Investigator’s opinion, understand the requirements which should be fulfilled for the participation in the study and are ready to follow them

•1. Withdrawal of informed consent.
•2. Erroneous inclusion (violation of inclusion and non-inclusion criteria).
•3. The Investigator’s or Sponsor’s decision to exclude a patient from the study due to clinically significant deviation from/violation of the protocol.
•4. Serious adverse events or adverse events (e.g. allergy) not meeting the seriousness criteria
•with the development of which, in the Investigator’s opinion, the further participation in
•the study will be detrimental for the patient’s health or well-being.
•5. Any adverse event (may be not drug related) requiring observation, procedures and/or drug
•treatment prohibited by this study protocol.
•6. Loss of contact with a patient and loss to the visit.
•7. The need of the therapy prohibited by the protocol.
•8. Patient became pregnant.

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