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Protein Therapy

Mim8 for Hemophilia A

Phase 3

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

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

Must have

Aged 1-11 years at the time of signing informed consent

Male and female participants with the diagnosis of congenital haemophilia A of any severity based on medical records

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from run-in initiation to end of treatment (week -26 to week 52)

Awards & highlights

Study Summary

This trialwill study a new medicine (Mim8) for preventing bleeds in kids with haemophilia A, with or without inhibitors, over 54-98 weeks.

Who is the study for?

This trial is for children aged 1-11 with severe haemophilia A, regardless of whether they have inhibitors. They must have used FVIII concentrate or a bypassing agent recently and be able to follow the study plan. Children can't join if they've had thromboembolic disease treatment (except certain past catheter-associated thrombosis), other coagulation disorders, conditions that increase bleeding or thrombosis risk, hepatic dysfunction, high serum creatinine levels, recent participation in another interventional study, mental incapacity or lack of parental support.Check my eligibility

What is being tested?

The trial tests Mim8 as a preventive treatment for bleeds in children with haemophilia A. Mim8 will be injected under the skin and compared to other medicines over approximately one to two years. If participants experience bleeds during the trial, additional treatments may be provided.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with similar treatments include injection site reactions like pain or swelling, potential allergic reactions to medication components and increased risk of developing antibodies against the medicine which might reduce its effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 11 years old.

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I have been diagnosed with congenital haemophilia A of any severity.

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I have severe haemophilia A with FVIII activity below 1%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from run-in initiation to end of treatment (week -26 to week 52)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from run-in initiation to end of treatment (week -26 to week 52)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from run-in initiation to end of treatment (week -26 to week 52) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of treatment emergent adverse events

Secondary outcome measures

Change in participants' treatment burden using the Hemo TEM (Haemophilia treatment experience measure)

Change in physical function domain of PEDS QL (Paediatric Quality of Life inventory) Generic Core Scales

Consumption of factor product per bleed treatment (number of injections)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mim8Experimental Treatment1 Intervention

52-week treatment period with a part 1 and part 2, where all participants receive Mim8 prophylaxis

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,998 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

106 Previous Clinical Trials

139,756 Total Patients Enrolled

Media Library

Mim8 (Protein Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05306418 — Phase 3

Haemophilia A Research Study Groups: Mim8

Haemophilia A Clinical Trial 2023: Mim8 Highlights & Side Effects. Trial Name: NCT05306418 — Phase 3

Mim8 (Protein Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05306418 — Phase 3

Frequently Asked Questions

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

How many people can join this clinical trial at the most?

"That is correct. Currently, the study is looking for 70 patients that meet specific inclusion criteria from 9 different hospitals or clinics."

Answered by AI

Are there prerequisites to joining this research project?

"The ideal candidate for this clinical trial must have hemophilia a, be between 1 and 11 years old. Right now, there are 70 open slots for this study."

Answered by AI

Are there any recorded side effects of Mim8?

"The Power team rates the safety of Mim8 as a 3. This is due to it being a Phase 3 trial, which means that there is some evidence supporting its efficacy, as well as multiple rounds of data confirming its safety."

Answered by AI

Are mature adults welcome in this research project?

"This study is looking for children who have not yet reached their 11th birthday but are at least 1 year old."

Answered by AI

At how many different locations can participants take part in this trial?

"There are 9 locations currently enrolling patients for this study, with sites in Toronto, Hershey, Atlanta and other cities. If you wish to enroll it is recommended that you select the site closest to your location to minimize travel time and inconvenience."

Answered by AI

Are we still looking for more test subjects for this experiment?

"The listing for this clinical trial on clinicaltrials.gov shows that it is currently looking for participants. The trial was first posted on April 4th, 2020 and the most recent update was November 10th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors

2022. "A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05306418.

All > Hemophilia A