Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
Conditions
Interventions
Intervention1: PZN-128: Romiplostim
The safety and efficacy of romiplostim have been evaluated for up to 5 years of continuous treatment. In clinical trials, treatment with Romiplostim resulted in dos
Sponsors
PHARMASYNTEZ-NORD JSC
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 Investigatorâ??s opinion, understand the requirements which should be fulfilled for the participation in the study and are ready to follow them
Exclusion criteria
Exclusion criteria: 1. Withdrawal of informed consent. 2. Erroneous inclusion (violation of inclusion and non-inclusion criteria). 3. The Investigatorâ??s or Sponsorâ??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 Investigatorâ??s opinion, the further participation in the study will be detrimental for the patientâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who required emergency therapy to prevent clinically significant bleeding. Timepoint: Number (percentage) of patients with persistent response to treatment determined as platelet count 50â??Ã?â??109 /L for 6 weeks of last 8-week therapy period in the absence of emergency therapy for relief of hemorrhagic synd | — |
Secondary
| Measure | Time frame |
|---|---|
| Number (percentage) of patients with platelet counts â?¥ 250â??Ã?â??109 /L for â?¥ 8 weeksTimepoint: Median time 7 weeks with a platelet response (i.e., the time when platelet counts were â?¥ 250â??Ã?â??109 /L during the therapy). â?¢ Percentage of patients who required emergency therapy to prevent clinically significant bleeding. | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Umakanta Sahoo
GCT Pharma Research (India) Pvt. Ltd.
Outcome results
None listed