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Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

NCT02267226 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-01-15

Study results available
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Summary

The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.

Conditions

  • Congenital Fibrinogen Deficiency

Interventions

DRUG

Octafibrin

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Cristina Solomon, MD · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-02-14
Completion
2018-02-14

Countries

  • United States
  • Bulgaria
  • India
  • Iran
  • Lebanon
  • Russia
  • Saudi Arabia
  • Turkey (Türkiye)
  • United Kingdom

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 NCT02267226 on ClinicalTrials.gov