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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05776069




Registration number
NCT05776069
Ethics application status
Date submitted
8/03/2023
Date registered
20/03/2023

Titles & IDs
Public title
Study of VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease (VIVID)
Scientific title
A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease and Other Bleeding Disorders (VIVID)
Secondary ID [1] 0 0
VGA039-CP001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Von Willebrand Diseases 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VGA039
Other interventions - Placebo
Treatment: Drugs - VGA039

Placebo comparator: Part 1 - Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined

Experimental: Part 2 - Cohorts A-H IV or SC VGA039 dose to be determined

Experimental: Part 3 - Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined

Experimental: Part 4 - Cohorts of VGA039 single dose for surgical prophylaxis

Experimental: Part 5 - Multiple doses of VGA039 in open label extension


Treatment: Drugs: VGA039
Single doses of VGA039

Other interventions: Placebo
Single doses of Placebo

Treatment: Drugs: VGA039
Multiple doses of VGA039
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Timepoint [1] 0 0
From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
Secondary outcome [1] 0 0
Plasma Concentrations of single IV and SC doses of VGA039
Timepoint [1] 0 0
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Secondary outcome [2] 0 0
Pharmacodynamics of single IV and SC doses of VGA039
Timepoint [2] 0 0
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Secondary outcome [3] 0 0
Incidence of Anti-drug antibodies to VGA039
Timepoint [3] 0 0
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively

Eligibility
Key inclusion criteria
Key Inclusion Criteria (All Subjects)

* Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
* Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
* No clinically significant laboratory, ECG, or vital signs results.

Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2

Additional Key Inclusion Criteria (for Subjects in Part 2 Only)

* Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
* Hemoglobin level = 8 g/dL and platelet count = 150 × 109/L at Screening.
Minimum age
12 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Key Criteria (All Subjects)

* Use of hormonal contraceptives within 56 days prior to administration of the study drug.
* Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
* Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
* History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.

Additional Key Exclusion Criterion (Subjects in Part 1 Only)

• Baseline FVIII activity > 150 IU/dL.

Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)

* Baseline FVIII activity > 50 IU/dL.
* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Queenlan
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio De Janeiro
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
India
State/province [14] 0 0
Mumbai
Country [15] 0 0
South Africa
State/province [15] 0 0
Johannesburg
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Edgbaston
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Hampshire
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vega Therapeutics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
650-466-8041
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05776069