← Back to Search

Monoclonal Antibodies

Part 2 for Von Willebrand Disease

Phase 1
Recruiting
Research Sponsored by Vega Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
Subjects, 18 to 60 years of age, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study drug administration until 15 or 8 weeks after iv or sc study drug administration, respectively
Awards & highlights

Study Summary

This trial is being conducted to test the safety and effectiveness of a drug called VGA039 in both healthy subjects and patients with Von Willebrand disease. The drug will be given through either an intravenous

Who is the study for?
This trial is for adults aged 18-60 who are generally healthy or have Von Willebrand Disease (VWD) with a history of bleeding or bruising. Healthy participants must have normal lab results and vital signs, while those with VWD need hemoglobin levels ≥ 8 g/dL and platelet count ≥ 150 × 109/L. People using hormonal contraceptives recently or with certain blood disorders can't join.Check my eligibility
What is being tested?
The study tests VGA039's safety and effects when given once via IV or SC to healthy volunteers and VWD patients. It's a Phase 1a trial, meaning it's an early-stage study focusing on how the drug behaves in the body (pharmacokinetics) and its impact on the disease (pharmacodynamics).See study design
What are the potential side effects?
Since this is a Phase 1a trial, specific side effects of VGA039 aren't listed yet as it aims to determine safety and tolerability. However, common side effects in such trials may include injection site reactions, headaches, nausea, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Von Willebrand Disease and experience bleeding or bruising.
Select...
I am between 18 and 60 years old.
Select...
I have a genetic condition related to blood clotting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until 15 or 8 weeks after iv or sc study drug administration, respectively
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 15 or 8 weeks after iv or sc study drug administration, respectively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Secondary outcome measures
Incidence of Anti-drug antibodies to VGA039
Pharmacodynamics of single IV and SC doses of VGA039
Plasma Concentrations of single IV and SC doses of VGA039

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2Experimental Treatment1 Intervention
Cohorts A-H IV or SC VGA039 dose to be determined
Group II: Part 1Placebo Group2 Interventions
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vega Therapeutics, IncLead Sponsor

Frequently Asked Questions

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

To what extent does Part 2 of the treatment pose risks to patients?

"Based on our evaluation, Part 2 of the trial is assigned a safety rating of 1. This reflects its Phase 1 status, indicating limited available data regarding both safety and efficacy."

Answered by AI

Is the inclusion criteria for this clinical trial limited to participants below the age of 40?

"To be eligible for this trial, individuals must fall within the age range of 18 to 60. It is important to note that there are separate clinical trials available for patients who are under the age of 18 (with a total count of 10) and those who are over the age of 65 (with a total count of 6)."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"To proceed with this clinical trial, we are in need of 64 eligible candidates who meet the specified inclusion criteria. Patient recruitment can take place at various locations, including the University of Colorado School of Medicine in Aurora, Colorado and Vanderbilt University Medical Center in Nashville, Tennessee."

Answered by AI

Are there multiple Canadian sites conducting this research study?

"This trial is currently being conducted at 6 different institutions, including the University of Colorado School of Medicine in Aurora, Vanderbilt University Medical Center in Nashville, and Charlotte Maxeke Johannesburg Academic Hospital in Johannesburg. Additionally, there are 3 other undisclosed locations where the study is taking place."

Answered by AI

Are individuals currently able to actively enroll in this research study?

"Indeed, the information available on clinicaltrials.gov confirms that this investigation is actively seeking suitable candidates. The study was initially posted on March 16th, 2023 and recently updated on December 19th, 2023. A total of 64 participants will be enrolled across six different locations."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease
2023. "Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776069.
All > Von Willebrand Disease
~20 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top