ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia | NCT04256148

Studies
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

NCT04256148

Sponsor

Alexion Pharmaceuticals, Inc.

Status

Withdrawn

Last Update Posted

Jul 13, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Warm Autoimmune Hemolytic Anemia

Interventions

ALXN1830
Placebo

Countries

United States

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study is withdrawn due to the global impact of the COVID-19 pandemic.

Expanded Access Info

Start Date

Jul 2021Estimated

Primary Completion Date

Oct 30, 2022Estimated

Completion Date

Apr 30, 2023Estimated

First Submitted Date

Jan 27, 2020

First Submission Date that Met QC Criteria

Feb 3, 2020

First Posted Date

Feb 5, 2020Actual

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

Jul 9, 2020

Last Update Posted Date

Jul 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

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

The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).

Detailed Description

This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ALXN1830 Dosing Regimen 1	Experimental	Biological: ALXN1830
ALXN1830 Dosing Regimen 2	Experimental	Biological: ALXN1830
ALXN1830 Dosing Regimen 3	Experimental	Biological: ALXN1830
Placebo	Active Comparator	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALXN1830	Biological	Administered via intravenous (IV) infusion	ALXN1830 Dosing Regimen 1 ALXN1830 Dosing Regimen 2 ALXN1830 Dosing Regimen 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline		Baseline (Day 1) through Day 92

Secondary Outcomes

Measure	Description	Time Frame
Total Number Of Units Of Packed Red Blood Cells (pRBCs) Transfused		Day 15 through Day 92
Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire		Baseline, Day 92

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
Failed or not tolerated at least 1 prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
Hemoglobin < 10 g/dL and ≥ 6 g/dL
Positive direct antiglobulin test (Coombs) (IgG positive, complement C3 [C3] positive or negative)
Evidence of active hemolysis including any of the following: a) Lactate dehydrogenase (LDH) > upper limit of normal (ULN), b) Haptoglobin < lower limit of normal (LLN), c) Indirect bilirubin > ULN
Total IgG > 500 mg/dL

Key Exclusion Criteria:

Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexion Study Site		Whittier	California	90602	United States

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

Intervention Browse Module

MeSH Terms

ID	Term
C000708950	orilanolimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided