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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

Page last updated: August 23, 2015

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