A Study to compare the efficacy and safety of PZN-128 in treatment chronic idiopathic thrombocytopenic purpura.
- Conditions
- Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2023/10/058677
- Lead Sponsor
- PHARMASYNTEZ-NORD JSC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients who required emergency therapy to prevent clinically significant <br/ ><br>bleeding. <br/ ><br> <br/ ><br>Timepoint: Number (percentage) of patients with persistent response to treatment determined as platelet count 50 × 109 <br/ ><br>/L for 6 weeks of last 8-week therapy period in the absence of emergency therapy for relief of hemorrhagic synd
- Secondary Outcome Measures
Name Time Method umber (percentage) of patients with platelet counts = 250 × 109 <br/ ><br>/L for = 8 weeksTimepoint: Median time 7 weeks with a platelet response (i.e., the time when platelet counts were = <br/ ><br>250 × 109 <br/ ><br>/L during the therapy). <br/ ><br>• Percentage of patients who required emergency therapy to prevent clinically significant <br/ ><br>bleeding.