← Back to Search

Monoclonal Antibodies

Single or Multiple ascending dose of HMB-001 for Glanzmann's Thrombasthenia

Phase 1 & 2

Recruiting

Research Sponsored by Hemab ApS

Eligibility Criteria Checklist

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

Must have

Glanzmann thrombasthenia with documented abnormal, diagnostic platelet aggregometry plus deficiency of the αIIbβ3 (GPIIb/GPIIIa) receptor via flow cytometry or genetic diagnosis

Participants must meet specified baseline organ function indicated by laboratory criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to day 339/eot/et/eos

Awards & highlights

Study Summary

This trial is studying the safety, effectiveness, and dosage levels of a drug called HMB-001 in people with Glanzmann Thrombasthenia. The trial will assess different doses of the

Who is the study for?

This trial is for individuals with Glanzmann Thrombasthenia, a rare bleeding disorder. Participants should be willing to undergo various tests and follow-ups. Specific details on who can or cannot participate are not provided here, but typically include factors like age, health status, and the severity of their condition.Check my eligibility

What is being tested?

The study is testing HMB-001's safety, how well it's tolerated by patients' bodies (tolerability), how it moves through and affects the body (pharmacokinetics/pharmacodynamics), and its effectiveness in preventing bleeds in Glanzmann Thrombasthenia patients. It has three parts: Part A tests single doses; Part B multiple doses over 3 months; Part C continues treatment from Part B for about 9 months.See study design

What are the potential side effects?

While specific side effects of HMB-001 are not listed here, common ones may include reactions at the injection site, potential allergic responses to new medication, general discomforts such as headaches or nausea, and any unique side effects related to how this drug interacts with blood clotting processes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have Glanzmann thrombasthenia with confirmed abnormal platelet function and a specific receptor deficiency.

Select...

My organ functions meet the required health standards.

Select...

I am between 18 and 65 years old.

Select...

I am a man who can father children and agree to use effective birth control and not donate sperm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to day 339/eot/et/eos

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to day 339/eot/et/eos

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 339/eot/et/eos for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part A: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters

Part A: Safety as assessed by the incidence of treatment-emergent adverse events (AEs)

Part B: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annual treated bleed rate (ATBR)

+6 more

Secondary outcome measures

Part A: Anti-drug antibody (ADA) formation

Part A: PK parameters: Area under the curve from time zero to extrapolated infinite time (AUCinf)

Part A: PK parameters: Area under the curve from time zero to last quantifiable concentration (AUClast)

+44 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single or Multiple ascending dose of HMB-001Experimental Treatment1 Intervention

Open-label, single or multiple ascending dose of HMB-001

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hemab ApSLead Sponsor

2 Previous Clinical Trials

622 Total Patients Enrolled

1 Trials studying Glanzmann's Thrombasthenia

122 Patients Enrolled for Glanzmann's Thrombasthenia

Frequently Asked Questions

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

Is the age limit for participation in this study restricted to individuals below 50 years old?

"To be eligible for this clinical investigation, individuals must satisfy the age criterion of being at least 18 years old and not exceeding 65 years."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"At present, patient enrollment is ongoing at 17 different sites for this trial. These include locations in New Orleans, London, Pittsburgh, and several others. To minimize travel requirements if you decide to participate, it is advisable to select the clinic closest to your location."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"To be eligible for enrollment in this clinical trial, prospective participants must have a confirmed diagnosis of Glanzmann's thrombasthenia and fall within the age range of 18 to 65. The study aims to recruit a total of 57 individuals meeting these criteria."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"To meet the enrollment target, a total of 57 eligible patients who satisfy the defined inclusion criteria are needed for this study. Patients have the option to participate from various locations, such as Tulane University Medical Center (Part B/C) in New Orleans, Louisiana and Royal Free London NHS Foundation Trust (Part B/C) in London, Pennsylvania."

Answered by AI

Is the current clinical trial open for enrollment?

"As per clinicaltrials.gov, this ongoing trial is actively seeking eligible participants. The study was initially posted on December 13th, 2022 and last updated on January 9th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

2022. "A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06211634.

All > Paid Studies Seattle > Paid Studies Minneapolis