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Post-marketing safety observation study of Ormutivimab Injection

Post-marketing safety observation study of Ormutivimab Injection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094152
Enrollment
Unknown
Registered
2024-12-17
Start date
2024-12-17
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Interventions

Injection of Ormutivima in rabies-exposed patients:NA

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Rabies virus exposed persons aged 2 years or older at enrollment. 2) The subjects were treated with Ormutivima during PEP and had completed PEP for >=7 days and within 90 days after administration. 3) Subjects or their legal guardians expressed informed consent through telephone. They were able and willing to comply with the requirements of the study protocol and cooperate with the study arrangements.

Exclusion criteria

Exclusion criteria: 1) Participate enroll in other drug or vaccine clinical trials during the planned study period. 2) The investigator believes that the subject is in any condition that may interfere with the assessment of the study.

Design outcomes

Primary

MeasureTime frame
Body temperature;

Secondary

MeasureTime frame
Adverse reactions;

Countries

China

Contacts

Public ContactCheng Liu

Peking University First Hospital

Chengliu218@pku.edu.cn+86 10 83572288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026