Postmarketing safety evaluation of recombinant anti-Rho (D) immunoglobuli
Phase 4
Completed
- Conditions
- Health Condition 1: O360- Maternal care for rhesus isoimmunization
- Registration Number
- CTRI/2021/11/038206
- Lead Sponsor
- Bharat Serums and Vaccines Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Rh negative female subjects = 18 years of age with negative ICT (nonsensitized).
2. Rh negative female subjects who would receive AntiD™ as per approved indications.
3. Subjects able to adhere to the study visit schedule and other protocol requirements.
4. Subjects willing to participate in the study by giving written informed consent.
Exclusion Criteria
1. Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the trial.
2. Subjects participating in another clinical trial in the four weeks before the screening visit.
3. History of anaphylactic or other severe systemic reaction to immunoglobulins.
4. Subjects requiring blood transfusion.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidences of Serious adverse events (SAEs) and adverse events (AEs) throughout the studyTimepoint: Throughout the study <br/ ><br>Day 1, Day 3, Day 28
- Secondary Outcome Measures
Name Time Method o secondary outcome.Timepoint: No secondary outcome