Clinical trialNCT02256917CompletedPhase 3Interventional

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

SponsorOctapharmaEnrollment58Severe Haemophilia A

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Craig M Kessler, MD
Georgetown University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

30 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Octapharma Research Site
Edmonton, Alberta, Canada
Octapharma Research Site
St. John's, Newfoundland and Labrador, Canada
Mcmaster University
Hamilton, Ontario, Canada

Croatia

University Hospital Centre Zagreb
Zagreb, Croatia

Finland

Helsinki University Hospital
Helsinki, Finland

France

Centre Régional de Traitement de L'Hémophilie
Bron, France
Chu Estaing
Clermont-Ferrand, France
Centre Hospitalier Universitaire Félix Guyon
La Réunion, France
Centre Régional de Traitement de L'Hémophilie
Nantes, France
Hôpital Purpan - Centre de Traitment Regional de L'Hemophilie Pole
Toulouse, France

Japan

Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hospital of the Univ of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
St. Marianna Univ School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Gunma University Hospital
Maebashi, Japan
Osaka National Hospital
Osaka, Japan
Ogikubo Hospital
Tokyo, Japan
Teikyo University Hospital
Tokyo, Japan

Netherlands

University Medical Center Groningen
Groningen, Netherlands

North Macedonia

Phi Institute of Transfusion Medicine of Republic of Macedonia
Skopje, North Macedonia

Slovenia

University Medical Centre Ljubljana
Ljubljana, Slovenia

United States

Octapharma Research Site
Sacramento, California, United States
Octapharma Research Site
Aurora, Colorado, United States
Octapharma Research Site
Washington D.C., District of Columbia, United States
Octapharma Research Site
Miami, Florida, United States
Octapharma Research Site
Chicago, Illinois, United States
Octapharma Research Site
Indianapolis, Indiana, United States
Octapharma Research Site
Memphis, Tennessee, United States
Octapharma Research Site
Houston, Texas, United States
Octapharma Research Site
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Human cl rhFVIII

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2015
Primary completion: 30 Sept 2018
Completion: 30 Sept 2018
Last update posted: 19 Jan 2021
Registered enrollment: 58
Registry id: NCT02256917

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.