CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 74 enrolled
Drug / intervention
Recombinant Factor VIII (BAY81-8973) +3 morebiological
Likely dose
Recombinant Factor VIII (BAY81-8973) 50 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01029340
NCT01029340Phase 3Completed
CompareCT.gov

A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy

Bayer·interventional·Posted Dec 9, 2009·Updated Nov 28, 2016

In Brief

A Phase 3 clinical trial evaluating Recombinant Factor VIII (BAY81-8973) and Recombinant Factor VIII (Kogenate FS, BAY14-2222) for Blood Coagulation Disorders and Hemophilia A. Completed, enrolled 74 participants across 60 sites in 22 countries.

Detailed Summary

The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Coagulation Disorders, Hemophilia A
CountriesArgentina, Austria, Croatia, Denmark, Germany, Hong Kong, India, Indonesia, Israel, Italy, Norway, Pakistan, Poland, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartDec 1, 2009
Primary CompletionJun 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.6 years ago

Interventions

Recombinant Factor VIII (BAY81-8973)biological

Single dose of BAY81-8973 crossed over to single dose of Kogenate FS

Recombinant Factor VIII (Kogenate FS, BAY14-2222)biological

Single dose of Kogenate FS crossed over to Single dose of BAY81-8973

Recombinant Factor VIII (BAY81-8973)biological

Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.

Recombinant Factor VIII (BAY81-8973)biological

Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks