China ADVATE PTP Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-26

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Previously Treated Patients (PTPs)

PTPs will participate sequentially with:

Part 1: Pharmacokinetic parameters of ADVATE measured in subset of 24 participants, consisting of:

* 12 adults (\>12 years of age)
* 12 children (≤12 years of age)

Part 2: On-demand treatment with ADVATE for 6 months

Part 3: Prophylaxis regimen with ADVATE for 6 months

Group Type EXPERIMENTAL

Octocog alfa (recombinant human coagulation factor VIII)

Intervention Type BIOLOGICAL

* Part 1: Pharmacokinetic (PK) analysis - Subset of 24 participants
* Part 2: On-demand treatment regimen
* Part 3: Prophylaxis treatment regimen

Interventions

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Octocog alfa (recombinant human coagulation factor VIII)

* Part 1: Pharmacokinetic (PK) analysis - Subset of 24 participants
* Part 2: On-demand treatment regimen
* Part 3: Prophylaxis treatment regimen

Intervention Type BIOLOGICAL

Other Intervention Names

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ADVATE

Eligibility Criteria

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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

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

Eligible Sex

MALE

Accepts Healthy Volunteers

No