Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Anti... | NCT01412047

Studies
Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

NCT01412047

Sponsor

Alexion Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Oct 18, 2017Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Paroxysmal Nocturnal Hemoglobinuria
PNH

Interventions

Not provided

Countries

United States
Australia
Belgium
France
Germany
Ireland
Italy
Netherlands
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 30, 2013Actual

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Aug 5, 2011

First Posted Date

Aug 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

How does long term treatment with Soliris affect HAHA in PNH patients?

Detailed Description

To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To summarize the proportion of patients with neutralizing HAHA antibodies.		Six (6) months

Secondary Outcomes

Measure	Description	Time Frame
To summarize the proportion of patients with non-neutralizing HAHA antibodies.		Six (6) months
To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies.		Six (6) months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PNH patients who previously participated in study E05-001;
Patients who have an eculizumab naive serum sample for comparison;
Patients who currently used commerical Soliris;
Patients who are willing and able to gie written informed consent.

Exclusion Criteria:

There are no exclusion criteria for this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with PNH previously enrolled in study E05-001, who have a eculizumab naive serum sample available for comparison, and who are currently receiving treatment with commerical Soliris.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camille Bedrosian, MD	Alexion Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Park Hematology Oncology		Englewood	Colorado	80113	United States
Cleveland Clinic Florida

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006457	Hemoglobinuria, Paroxysmal

Ancestor Terms

ID	Term
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided