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Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.

NCT01666249 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2022-11-02

No results posted yet for this study

Summary

This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).

Conditions

  • Pregnancy; Fetomaternal Hemorrhage

Interventions

BIOLOGICAL

Immunoglobulin Anti-RhD

Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).

Sponsors & Collaborators

  • Panamerican Medical Supply

    collaborator OTHER

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Regina M Doi, physician · Azidus Brasil Scientific Research and Development Ltda

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-11-30
Completion
2020-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01666249 on ClinicalTrials.gov