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Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225287
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ra Pharmaceuticals

Brief Summary:
The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical study.

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria (PNH) Drug: Zilucoplan (RA101495) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study
Drug: Zilucoplan (RA101495)
Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.




Primary Outcome Measures :
  1. Adverse Events and Serious Adverse Events Profile [ Time Frame: Safety events will be assessed at each study visit through the completion of the study (approximately 2.5 years) ]
    Adverse Events and Serious Adverse Events Profile



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan (RA101495) PNH study
  • Evidence of ongoing clinical benefit in the opinion of the Investigator

Exclusion criteria:

  • History of meningococcal disease
  • Current systemic infection or suspicion of active bacterial infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225287


Locations
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United States, California
Investigative Site
Duarte, California, United States, 91010
United States, Illinois
Investigative Site
Chicago, Illinois, United States, 60612
United States, New York
Investigative Site
Manhasset, New York, United States, 11042
United States, North Carolina
Investigative Site
Durham, North Carolina, United States, 27710
United States, Texas
Investigative Site
Dallas, Texas, United States, 75390
Australia
Investigative site
Gosford, Australia
Investigative site
Melbourne, Australia
Denmark
Investigative Site
Copenhagen, Denmark
Finland
Investigative Site
Helsinki, Finland
Germany
Investigative Site
Essen, Germany
Investigative Site
Ulm, Germany
Hungary
Investigative Site
Budapest, Hungary
New Zealand
Investigative Site
Christchurch, New Zealand
Investigative Site
Hamilton, New Zealand
United Kingdom
Investigative Site
Leeds, United Kingdom
Investigative Site
London, United Kingdom
Sponsors and Collaborators
Ra Pharmaceuticals
Investigators
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Study Chair: Dr. Anita Hill St James' Institute of Oncology

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Responsible Party: Ra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03225287     History of Changes
Other Study ID Numbers: RA101495-01.202
2016-003523-34 ( EudraCT Number )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases