Other Clinical Trial - Extension Study of Eculizumab in Patients With

Clinical Trial Description

An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies. ;

Study Design

Related Conditions & MeSH terms

Hemoglobinuria
Hemoglobinuria, Paroxysmal
Paroxysmal Hemoglobinuria, Nocturnal

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03157635` - Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria	Phase 1/Phase 2
Completed	`NCT00004464` - Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria	Phase 2
Completed	`NCT00130000` - Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria	Phase 3

See also

Status

Clinical Trial

Phase

Active, not recruiting

NCT03157635 - Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

Phase 1/Phase 2

Completed

NCT00004464 - Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

Phase 2

Completed

NCT00130000 - Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00122317
Study type	Interventional
Source	Alexion Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	May 2005
Completion date	October 2008

Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms