BAX 855 Continuation

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

Key facts

Study ID

NCT01945593

Run by

Baxalta now part of Shire

People needed

218

Starts

2013-10-15

Expected to finish

2018-03-02

Last updated by the study team

2021-05-24

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants Transitioning from Other BAX 855 Studies:
• Participants transitioning from other BAX 855 studies can be provided with the continuation study informed consent form (ICF) prior to the end of study visit to review and consider participation in this continuation study. These participants will complete any additional screening assessments within 2 weeks of the previous study's end of study visit and will return to the study site within 6 (± 1) weeks of the previous study end of study visit to confirm eligibility for this continuation study.
• Participants transitioning from other BAX 855 studies who meet ALL of the following criteria are eligible for this study:
• Participant has completed a previous BAX 855 study and is willing to immediately transition into this continuation study.
• Participant is ≤75 years of age at screening of the previous BAX 855 study.
• Participant continues to have a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged < 16 years) performance score of ≥ 60.
• Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory at screening.
• Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.
• If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
• Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol.
• BAX 855 Naïve Participants:
• BAX 855 naïve participants who are ≥ 12 years of age can only be enrolled in this continuation study after enrollment in the phase 2/3 pivotal study is closed. BAX 855 naïve participants who are < 12 years of age can only be enrolled in this continuation study after enrollment in the pediatric previously treated patient (PTP) study is closed.
• Enrolment of BAX 855 naïve participants will only start once the sponsor has notified the study sites accordingly.
• BAX 855 naïve participants who meet ALL of the following criteria are eligible for this study:
• Participant is ≤75 years of age at screening.
• Participant is naïve to BAX 855.
• Participant has severe hemophilia A (FVIII clotting activity < 1%) as confirmed by central laboratory at screening after at least a 72-hour washout period.
• Participant aged ≥ 6 years has documented previous treatment with plasma-derived FVIII or rFVIII for ≥ 150 exposure days (EDs).
• Participant aged < 6 years has documented previous treatment with plasma-derived FVIII concentrates or rFVIII for ≥ 50 EDs.
• Participant is currently receiving prophylaxis or on-demand therapy with FVIII.
• Participant has a Karnofsky (for participants aged ≥ 16 years) or Lansky (for participants aged < 16 years) performance score of ≥ 60.
• Participant is HIV-; or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3, as confirmed by central laboratory at screening.
• Participant is HCV- by antibody or PCR testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.
• If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
• Participant and/or legally authorized representative is willing and able to comply with the requirements of the protocol.

Where it is running

• University of Colorado — Aurora, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Children's Mercy Hospitals & Clinics — Kansas City, Missouri, United States
• North Shore-Long Island Jewish Health System — New Hyde Park, New York, United States
• New York - Presbyterian/Weill Cornell Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Penn State Hershey Cancer Center — Hershey, Pennsylvania, United States
• Palmetto Health Richland — Columbia, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States
• Puget Sound Blood Group — Seattle, Washington, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Fremantle Hospital — Fremantle, Western Australia, Australia
• Landes-Frauen-und Kinderklinik Linz — Linz, Austria
• Phoenix Childrens Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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