CSL627_3001 Hemophilia A

Bleeding and Clotting Disorders

Protocol:CSL627_3001

Condition or Disease: Hemophilia A

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII SingleChain, CSL627) in Subjects with Severe Hemophilia A

Principal I investigator: Joseph Lasky III, MD

ALN-AT3SC-003 Hemophilia A or B

Bleeding and Clotting Disorders

Protocol:ALN-AT3SC-003

Condition or Disease: Hemophilia A or B

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

Principal I investigator: Joseph Lasky III, MD

More Info: //clinicaltrials.gov/ct2/show/NCT03417102

ALN-AT3SC-004 Hemophilia A or B

Bleeding and Clotting Disorders

Protocol:ALN-AT3SC-004

Condition or Disease: Hemophilia A or B

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

Principal I investigator: Joseph Lasky III, MD

More Info: //clinicaltrials.gov/ct2/show/NCT03417245

GENA-25 Hemophilia A

Bleeding and Clotting Disorders

Protocol:GENA-25

Condition or Disease: Hemophilia A

Study Type: Observational

Status: Open for enrollment

Study Title: PRactical utilization of Octapharma FVIII Concentrates in Previously Untreated and Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment (with Nuwiq, Octanate or Wilate) ‰ÛÒ A Real- World Efficacy and Safety Observational Study

Principal I investigator: Joseph Lasky III, MD

More Info: //clinicaltrials.gov/ct2/show/NCT03695978

1160.106 Venous thrombosis

Bleeding and Clotting Disorders

Protocol:1160.106

Condition or Disease: Venous thrombosis

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: Open-label, randomized, parallel-group, active-controlled, multi-centre, non-inferiority study of dabigatran etexilate versus standard of care for venous thromboembolism treatment in children from birth to less than 18 years of age: The DIVERSITY study

Principal I investigator: Alan Ikeda, MD

More Info: //clinicaltrials.gov/ct2/show/NCT01895777

1160.108 Venous Thromboembolism, Secondary Prevention

Bleeding and Clotting Disorders

Protocol:1160.108

Condition or Disease: Venous Thromboembolism, Secondary Prevention

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years

Principal I investigator: Alan Ikeda, MD

More Info: //clinicaltrials.gov/ct2/show/NCT02197416

1321.7 Hemorrhage

Bleeding and Clotting Disorders

Protocol:1321.7

Condition or Disease: Hemorrhage

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Study Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilate for the treatment and secondary prevention of venous thromboembolism.

Principal I investigator: Alan Ikeda, MD

More Info: //clinicaltrials.gov/ct2/show/NCT02815670

20101221 Immune Thrombocytopenia

Bleeding and Clotting Disorders

Protocol:20101221

Condition or Disease: Immune Thrombocytopenia

Study Type: Interventional (Clinical Trial)

Status: Closed for enrollment

Study Title: A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

Principal I investigator: Alan Ikeda, MD

More Info: //clinicaltrials.gov/ct2/show/NCT02279173

GENA-99 Hemophilia A

Bleeding and Clotting Disorders

Protocol:GENA-99

Condition or Disease: Hemophilia A

Study Type: Observational

Status: Open for enrollment

Study Title: Prospective, multinational, non-interventional post-authorisation study to document the long-term immunogenicity, safety, and efficacy of Human-cl rhFVIII (simoctocog alfa) in patients with haemophilia A treated in routine clinical practice

Principal I investigator: Joseph Lasky III, MD

More Info: //clinicaltrials.gov/ct2/show/NCT02962765