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Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A

NCT ID: NCT01863758

Last Updated: 2018-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-01-31

Brief Summary

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To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.

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Detailed Description

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There were 3 phases in this study: (1) An initial pharmacokinetic (PK) assessment in which participants received a single infusion of 60±5 IU/kg of Human-cl rhFVIII; blood samples were collected for 72 hours following the infusion. (2) Prophylactic Treatment-Phase I during which participants received infusions of 30-40 IU/kg of human-cl rhFVIII every other day or 3x/week for 1-3 months. (3) Prophylactic Treatment-Phase II during which the dose and dosing interval were determined individually from data gathered in the initial PK assessment. The maximum dosing interval with a dose of ≤ 60-80 IU/kg that maintains a trough level of ≥ 0.01 IU/mL was determined. Participants were treated for 6 months.

Conditions

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Severe Haemophilia 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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Human-cl rhFVIII

Up to 60-80 IU/kg of intravenous Human-cl rhFVIII was administered at an individually determined dose and dose interval.

Group Type EXPERIMENTAL

Human-cl rhFVIII

Intervention Type BIOLOGICAL

Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.

Interventions

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Human-cl rhFVIII

Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Severe haemophilia A (FVIII:C \< 1%) according to medical history.
* Male patients ≥ 18 years old.
* Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 exposure days (EDs).
* Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start.
* Immunocompetence (CD4+ count \> 200/microliter).
* HIV-negative, if positive, viral load \< 200 particles/microliter or \< 400,000 copies/mL.
* Freely given written informed consent

Exclusion Criteria

* Any coagulation disorder other than haemophilia A.
* Present or past FVIII inhibitor activity (\> 0.6 Bethesda Unit \[BU\])
* Severe liver or kidney disease.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University Vienna

Vienna, , Austria

Site Status

University Multiprofile Hospital for Active Treatment

Plovdiv, , Bulgaria

Site Status

Specialized Hospital for Active Treatment

Sofia, , Bulgaria

Site Status

Multiprofile Hospital for Active Treatment

Varna, , Bulgaria

Site Status

Vivantes Hospital in Friedrichshain

Berlin, , Germany

Site Status

SRH Kurpfalzklinik Heidelberg GMBH

Heidelberg, , Germany

Site Status

Hungarian National Healthcare Center

Budapest, , Hungary

Site Status

University of Debrecen, Medical and Health Science Center

Debrecen, , Hungary

Site Status

University Teaching Hospital in Bialystok, Teaching Department of Hematology with a Subdepartment of Vascular Diseases

Bialystok, , Poland

Site Status

University Clinical Center, Teaching Department of Hematology and Transplantology

Gdansk, , Poland

Site Status

Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology

Torun, , Poland

Site Status

Institute of Hematology and Transfusion Medicine, Depart. of Hemostatic Disorders and Internal Diseases

Warsaw, , Poland

Site Status

Sanador SRL

Bucharest, , Romania

Site Status

Louis Turcanu Emergency Clinical Children's Hospital

Timișoara, , Romania

Site Status

University Hospital Saint Cyril and Metod

Bratislava, , Slovakia

Site Status

University Hospital Martin, Department of Hematology and Transfusiology

Martin, , Slovakia

Site Status

Basingstoke and North Hampshire Hospital, Hemophilia, Hemostasis and Thrombosis Center

Basingstoke, , United Kingdom

Site Status

Royal London Hospital, Barts and the London Hemophilia Center

London, , United Kingdom

Site Status

Manchester Royal Infirmary, Department of Clinical Hematology

Manchester, , United Kingdom

Site Status

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Countries

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Austria Bulgaria Germany Hungary Poland Romania Slovakia United Kingdom

Other Identifiers

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GENA-21

Identifier Type: -

Identifier Source: org_study_id

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