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Complement Inhibitor

Pegcetacoplan for Cold Agglutinin Disease

Phase 3

Waitlist Available

Led By Bernd Jilma, MD

Research Sponsored by Swedish Orphan Biovitrum

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial will test whether a new medication can increase hemoglobin levels and help avoid transfusions in people with primary cold agglutinin disease.

Who is the study for?

This trial is for adults over 18 with primary Cold Agglutinin Disease (CAD) and low hemoglobin levels (≤9 g/dL). Participants must have updated vaccinations or agree to vaccinate, use contraception if of childbearing potential, and not have certain conditions like aggressive lymphoma, organ transplants, liver dysfunction, recent anti-complement therapies or rituximab treatments.Check my eligibility

What is being tested?

The study tests Pegcetacoplan against a placebo in increasing hemoglobin levels and reducing the need for transfusions in CAD patients. It's designed to see if this treatment is effective and safe compared to not receiving the active drug.See study design

What are the potential side effects?

While specific side effects are not listed here, Pegcetacoplan could potentially cause reactions at injection sites, infections due to immune system impact, or other unforeseen issues as it targets parts of the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response (R)

Secondary outcome measures

Change From Baseline to Week 24 in 12-item short form survey (SF-12)

Change From Baseline to Week 24 in Functional Assessment of Cancer Therapy-Anemia/Fatigue (FACT-An) Scale Score (Quality of Life)

Change From Baseline to Week 24 in five level EuroQol five dimensions questionnaire (EQ-5D-5L)

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PegcetacoplanActive Control1 Intervention

1080 mg, subcutaneus injection, twice weekly

Group II: PlaceboPlacebo Group1 Intervention

Sodium acetate, subcutaneus injection, twice weekly

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Swedish Orphan BiovitrumLead Sponsor

92 Previous Clinical Trials

12,457 Total Patients Enrolled

Luis López LazaroStudy DirectorSwedish Orphan Biovitrum AB

1 Previous Clinical Trials

12 Total Patients Enrolled

Bernd Jilma, MDPrincipal InvestigatorMedical University of Vienna

9 Previous Clinical Trials

1,074 Total Patients Enrolled

Media Library

Pegcetacoplan (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05096403 — Phase 3

Cold Agglutinin Disease Research Study Groups: Pegcetacoplan, Placebo

Cold Agglutinin Disease Clinical Trial 2023: Pegcetacoplan Highlights & Side Effects. Trial Name: NCT05096403 — Phase 3

Pegcetacoplan (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05096403 — Phase 3

Frequently Asked Questions

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

How does the Pegcetacoplan research compare to other similar investigations?

"In 2018, the first clinical trials for pegcetacoplan were completed at HealthONE Physician Care. As of now, there are 11 live trials and 8 completed trials. A majority of the current research is being conducted in Whittier, CA."

Answered by AI

What sort of side effects does Pegcetacoplan have on patients?

"With some efficacy data and multiple rounds of safety data, Pegcetacoplan scored a 3 for safety."

Answered by AI

Is this a novel approach to research?

"11 clinical trials are ongoing for pegcetacoplan as of July 1st, 2022. The first study was completed in 2018 and sponsored by Apellis Pharmaceuticals, Inc. In total, 164 cities across 26 countries have been involved in the 11 studies."

Answered by AI

How many individuals will be included in this experimental group?

"That is correct. The information available on clinicaltrials.gov demonstrates that this research is actively looking for participants. The trial was first posted on March 1st, 2022 and was updated on March 8th, 2022. There are two sites which are looking to enrol a total of 57 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

2022. "A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05096403.