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ALXN2050 for Liver Dysfunction

Phase 1
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must agree to receive prophylactic antibiotics to mitigate the potential risk of meningococcal infection.
Body weight must be at least 50.0 kilograms (kg) and body mass index (BMI) within the range of 18.0 - 40.0 kg/meter squared (inclusive) at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)
Awards & highlights

Study Summary

This trial will study how well a new drug works in people with different degrees of liver impairment.

Who is the study for?
This trial is for adults with varying degrees of liver dysfunction (Child-Pugh Classes A-C) and healthy controls matched by sex, race, age (+/- 10 years), and BMI (+/- 20%). Participants must not have liver cancer, be on a stable medication regimen, agree to use contraception and take antibiotics to prevent infection. Exclusions include fever or infection within 14 days before the study drug is given, recent blood donations or receipt of vaccines.Check my eligibility
What is being tested?
The trial studies how different levels of liver impairment affect the body's handling of ALXN2050. It aims to establish dosing guidelines for patients with impaired hepatic function. The study includes both those with liver issues and healthy individuals as controls to compare results.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will receive prophylactic antibiotics which can cause digestive upset or allergic reactions in some people. As this is an investigational drug, monitoring for any unexpected side effects will be part of the trial process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to take antibiotics to prevent meningitis.
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I weigh at least 50 kg and my BMI is between 18.0 and 40.0.
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I have liver cirrhosis due to hepatitis, alcohol, or fatty liver disease.
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My liver function is classified as mild to severe according to the Child-Pugh scale.
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My liver isn't working well, but I don't have liver cancer as shown by recent scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Maximum (Peak) Steady-state Plasma Concentration Of ALXN2050 (Cmax,ss)
+1 more
Secondary outcome measures
Number Of Participants Receiving ALXN2050 With Treatment-emergent Adverse Events

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Healthy ControlExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group II: Cohort 3: Severe IHFExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group III: Cohort 2: Moderate IHFExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group IV: Cohort 1: Mild IHFExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN2050
2021
Completed Phase 1
~250

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,166 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,387 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,241 Total Patients Enrolled

Media Library

ALXN2050 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05259085 — Phase 1
Liver Dysfunction Research Study Groups: Cohort 1: Mild IHF, Cohort 2: Moderate IHF, Cohort 3: Severe IHF, Cohort 4: Healthy Control
Liver Dysfunction Clinical Trial 2023: ALXN2050 Highlights & Side Effects. Trial Name: NCT05259085 — Phase 1
ALXN2050 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259085 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant pool for this research initiative?

"Affirmative. Based on the records hosted by clinicaltrials.gov, this research project is still seeking participants for enrollment. This endeavor was first initiated on April 7th 2022 and underwent a recent update on May 11th 2022; 36 recruits are necessary from two different medical facilities."

Answered by AI

Are there any prerequisites for enrollment in this clinical trial?

"This clinical trial requires 36 individuals of ages 18 to 80 who are suffering from impaired hepatic function. To be considered for participation, potential participants must meet the following criteria: Use contraceptives that adhere to local regulations., Have a mild (Child-Pugh score ≥5 and ≤6), moderate (Child-Pugh score ≥7 and ≤9) or severe (Child-Pugh score ≥10 and ≤15) degree of IHF., Demonstrate cirrhosis due to chronic hepatitis c virus infection, chronic hepatitis b infection, cryptogenic issues, alcohol abuse or nonalcoholic steatohepatitis via biopsy results, imaging"

Answered by AI

Does this trial extend to geriatric populations?

"This study is looking for participants aged 18 to 80. There are 50 trials that focus on patients younger than 18 and 373 clinical studies specifically targeting seniors above the age of 65."

Answered by AI

Is this clinical experiment presently seeking participants?

"Affirmative. Details available on clinicaltrials.gov demonstrate that this experimental study, initially published on April 7th 2022, is in the recruitment phase for 36 patients from 2 different sites. The data was last updated on May 11th 2022."

Answered by AI

Has ALXN2050 been granted regulatory assent by the FDA?

"As this is an early phase 1 trial, which features limited evidence of efficacy and safety, we gave ALXN2050 a score of one."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of ALXN2050 in Participants With Hepatic Impairment
2022. "Study of ALXN2050 in Participants With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05259085.
~12 spots leftby Apr 2025
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