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

Severe Haemophilia A Clinical Trial

Official title:
Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02256917
Study type	Interventional
Source	Octapharma
Contact
Status	Completed
Phase	Phase 3
Start date	May 2015
Completion date	September 2018

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02576795` - Gene Therapy Study in Severe Haemophilia A Patients (270-201)	Phase 1/Phase 2
Completed	`NCT01863758` - Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A	Phase 3
Recruiting	`NCT02314325` - Subclinical Joint Bleeding in Irish Adults With Severe Haemophilia A on Personalised Prophylaxis Regimens	Phase 4
Completed	`NCT02697370` - Efficacy and Cost Effectiveness of Pharmacokinetic Dosing in Haemophilia A	Phase 4