China ADVATE PTP Study
Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Octocog alfa (recombinant human coagulation factor VIII) (Biological)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Baxalta US Inc. Official(s) and/or principal investigator(s): Leon Rozen, MD, Study Director, Affiliation: Baxter Healthcare Corporation
Summary
The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in
the treatment and prevention of bleeding episodes (BEs)
Clinical Details
Official title: Study to Evaluate Efficacy and Safety of ADVATE in the Treatment of Previously Treated Patients With Hemophilia A
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Percentage of reduction in annualized bleed rate (ABR) during prophylactic treatment compared to ABR during on demand treatment
Secondary outcome: Number of units per kg body weight of ADVATE required to resolve a bleeding episode (BE)Number of infusions of ADVATE required to resolve a bleeding episode (BE) Overall evaluation of efficacy on a four-point scale (Excellent-Good-Fair-Poor) Annualized bleeding episode rates (ABR) according to bleed type and bleed etiology summarized by treatment regimen Inhibitor incidence Adverse events according to relatedness, seriousness, and severity Area under the plasma concentration/time curve from time 0 to infinity Mean Residence Time (MRT) Clearance (CL) Incremental Recovery (IR) at Cmax Elimination phase half-life Volume of distribution at steady state (Vss)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Main Inclusion Criteria:
- Ethnic Chinese
- is of any age
- has a documented diagnosis of severe or moderately severe hemophilia A (congenital
FVIII deficiency: baseline Factor VIII (FVIII) ≤ 2%)
- has documented and verified >50 exposure days (EDs) to FVIII (recombinant or plasma
derived)
- is receiving on-demand treatment with FVIII at the time of enrolment in this study
- has negative history of inhibitor development
- is HIV negative or HIV positive with stable disease and CD4+ count ≥ 200 cells per
mm^3
- is negative for Hepatitis C virus (HCV); Or participant is HCV positive with chronic
stable hepatitis as assessed by investigator
Main Exclusion Criteria:
- has prior history of hypersensitivity or anaphylaxis associated with receipt of FVIII
- is diagnosed with other bleeding disorder(s) other than hemophilia A, including but
not limited to thrombocytopenia (platelet count < 100000 /mL)
- has been exposed to an investigational product (IP) within 30 days prior to the
screening visit or is scheduled to participate in another clinical study involving an
IP or investigational device during participation in the study
- is planned, or likely to have surgery during the study period
- has end-stage renal failure or evidence of a severe or uncontrolled systemic disease
as judged by the investigator
- has active hepatic disease (alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) levels > 5 times the upper limit of normal)
- has clinical or laboratory evidence of severe liver impairment including (but not
limited to) a recent & persistent international normalized ratio (INR) >1. 4, and/or
the presence of splenomegaly and/or significant spider angioma on physical exam,
and/or a history of esophageal hemorrhage or documented esophageal varices
- is a family member of the investigator or site staff
Locations and Contacts
Beijing Children's Hospital Affiliated to Capital University of Medical Sciences, Beijing 100045, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
Hospital of Blood Disease, Chinese Academy of Medical Sciences, Tianjin 300020, China
Peking Union Medical College Hospital, Dongcheng District, Beijing 100730, China
Fujian Medical University Union Hospital, Fuzhou, Fujian 350001, China
Cangzhou Central Hospital, Cangzhou, Hebei 061001, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech/ Wuhan Union Hospital, Wuhan, Hubei 430022, China
Tongji Hospital of Tongji Medical College of Hongzhong Science and Techology University, Wuhan, Hubei 430030, China
Xiangya Hospital Central South University, Changsha, Hunan 410008, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China
The First Affiliated Hospital of College of Medicine, Zhengjiang University, Hangzhou, Zhejiang 310003, China
Additional Information
Starting date: June 2014
Last updated: June 26, 2015
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