Hemophilia A

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

NCT02172950 | PHASE 3 | INTERVENTIONAL

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

64 Sites

246 Participants

Recruiting

6 Years to 64 Years

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Find closest sites:

SUBMIT

Study Site

San Diego,California,United States,92103

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Aurora,Colorado,United States,80045

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Hartford,Connecticut,United States,06106

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Miami,Florida,United States,33136

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Chicago,Illinois,United States,60612

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New Orleans,Louisiana,United States,70112

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Dallas,Texas,United States,75390

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Houston,Texas,United States,77030

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Milwaukee,Wisconsin,United States,53226

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Melbourne,Australia,3052

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Nedlands,Australia,WA6009

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Perth,Australia,WA6000

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Graz,Austria,8036

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Linz,Austria,4020

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Wien,Austria,1090

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Wien,Austria,1090

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Saint John,Canada,E2L4L2

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Hradec Kralove,Czechia,50005

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Brest,France,29609

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Le Kremlin Bicetre,France,94270

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Lille Cedex,France,59037

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Nantes,France,44093

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Paris,France,75015

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Tbilisi,Georgia,0179

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Bonn,Germany,53127

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Frankfurt,Germany,60596

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Giessen,Germany,35385

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Hannover,Germany,30625

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Debrecen,Hungary,4032

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Dublin,Ireland,12

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Milano,Italy,20122

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Hyogo,Japan,663-8501

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Nagoya,Japan,466-8550

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Okayama,Japan,710-8602

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Saitama,Japan,339-8551

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Tokyo,Japan,160-0023

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Beirut,Lebanon,165191

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Kuala Lumpur,Malaysia,50400

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Amsterdam Zuidoost,Netherlands,1105AZ

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Nijmegen,Netherlands,6500

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Utrecht,Netherlands,3584

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Cebu City,Philippines,6000

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Davao City,Philippines,8000

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Gdansk,Poland,80-952

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Krakow,Poland,31-531

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Rzeszow,Poland,35-301

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Wroclaw,Poland,50-367

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Porto,Portugal,4200-319

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Bucharest,Romania,011026

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Timisoara,Romania,300011

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Parktown,South Africa,2193

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A Coruna,Spain,15006

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Barcelona,Spain,08035

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Madrid,Spain,28046

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Valencia,Spain,46026

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Luzern,Switzerland,6000

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Bangkok,Thailand,10330

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Bangkok,Thailand,10700

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Chiang Mai,Thailand,50200

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Khon Kaen,Thailand,40002

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Songkhla,Thailand,90110

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Dnipropetrovsk,Ukraine,49102

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Lviv,Ukraine,79044

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London,United Kingdom,NW32QG

Study Eligibility Criteria

Inclusion Criteria

PTPs:
* Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
* Males 0 to \<65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
PUPs:
* Males 0 to \<18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%)
* No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).
ITI substudy:
* PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

Exclusion Criteria

* Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
* Currently receiving a therapy not permitted during the study.
* Serum creatinine \> 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase \> 5 x upper limit of normal at Screening (if specified)
* Any first-order family (eg, siblings) history of FVIII inhibitors
* For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors

Additional Studies

Additional studies can be found at ClinicalTrials.gov