Phase 4
Completed N=25
RIXUBIS PMS India (RIXUBIS PMS)
Source: ClinicalTrials.gov NCT03565237 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS — 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS |
— | — |
| SECONDARY Number of Participants With TEAEs Related to RIXUBIS |
— | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Developed Binding Antibodies (Immunoglobulin G [IgG] and Immunoglobulin M [IgM]) to Factor IX (FIX) |
1 | — |
| SECONDARY Number of Participants Who Developed Binding Antibodies to Chinese Hamster Ovary (CHO) Proteins and rFurin |
0; 0 | — |
| SECONDARY Annualized Bleeding Rate (ABR) With Prophylactic Use of RIXUBIS |
0.914 | — |
| SECONDARY Rate of Success of RIXUBIS for Treatment of Bleeding Episodes |
100 | — |
Eligibility Criteria
Inclusion Criteria
- The participant or legally authorized representative (in case of study participants 1.4 hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- Participant has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of normal alanine aminotransferase (ALT), as confirmed by central laboratory at screening, or a documented INR > 1.5].
- Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening.
- Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia B.
- Participant's platelet count is < 100,000/mL.
- Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant's safety or compliance.
- Participant is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug (eg, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than antiretroviral chemotherapy.
- Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- Participant is a family member or employee of the investigator.
Data sourced from ClinicalTrials.gov (NCT03565237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.