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Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

NCT01575756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-03-09

Study results available
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Summary

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency

Conditions

  • Congenital Fibrinogen Deficiency
  • Afibrinogenemia

Interventions

BIOLOGICAL

Octafibrin

Octafibrin was supplied as a powder for reconstitution with water for injection.

BIOLOGICAL

Haemocomplettan® P or RiaSTAPTM

Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Sigurd Knaub, PhD · Octapharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Bulgaria
  • India
  • Iran
  • Switzerland
  • 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 NCT01575756 on ClinicalTrials.gov