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rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study

NCT06137092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-18

No results posted yet for this study

Summary

The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)

Conditions

  • Severe Hemophilia A

Interventions

DRUG

Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)

rFVIII-Fc, IV, 50 units/kg/ single dose, cross-over

Sponsors & Collaborators

  • AryoGen Pharmed Co.

    lead INDUSTRY

Principal Investigators

  • Aziz Eghbali, Assoc. Prof. · Iran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-22
Primary Completion
2023-09-27
Completion
2023-09-27

Countries

  • Iran

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 NCT06137092 on ClinicalTrials.gov