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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00879749
Registration number
NCT00879749
Ethics application status
Date submitted
8/04/2009
Date registered
10/04/2009
Date last updated
7/04/2011
Titles & IDs
Public title
Safety Study of Nexvax2 in Subjects With Coeliac Disease
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Scientific title
A Phase I Study to Determine Safety, Tolerability and Bioactivity of Nexvax2 in HLA DQ2+ Volunteers With Coeliac Disease Following a Long-term, Strict Gluten-free Diet
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Secondary ID [1]
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Nexvax2-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease
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Celiac Disease
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 9 micrograms Nexvax2
Other interventions - 30 micrograms Nexvax2
Other interventions - 90 micrograms Nexvax2
Other interventions - 60 micrograms Nexvax2
Other interventions - Up to 900 micrograms Nexvax2
Other interventions - Placebo
Placebo Comparator: Saline -
Experimental: Nexvax2 -
Other interventions: 9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration
Other interventions: 30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration
Other interventions: 90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration
Other interventions: 60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration
Other interventions: Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
Other interventions: Placebo
100 microlitres 0.9% sterile sodium chloride for injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
Key
1. Age 18 to 60 years (inclusive)
2. Have coeliac disease meeting the following criteria:
- the Principal Investigator is satisfied coeliac disease has been correctly
diagnosed,
- HLA DQ2 genotype (both HLA DQA1*05 and DQB1*02, homo- or hetero-zygous),
- no known or suspected gluten exposure for 2 months prior to enrolment
- were prescribed and have intended to follow a gluten-free diet for at least one
year
- antibodies to tissue transglutaminase (tTG) IgA and/or deamidated gliadin peptide
(DGP) IgA and IgG within normal reference range at time of screening.
3. Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or
using at least two acceptable and highly effective birth control methods.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subjects possess the genes encoding HLA DQ8 (either DQA1*03 or DQB1*0302).
2. Uncontrolled complications of coeliac disease which, in the opinion of the
Investigator, would impact immune response or pose an increased risk to the subject.
3. Systemic biological agents less than 6 months prior to Day 1.
4. Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days
prior to Day 1.
5. Any of the following laboratory abnormalities at Screening:
- ALT, AST or alkaline phosphatase (ALP) > 1.5 times the upper limit of normal
(ULN)
- Calculated creatinine clearance < 80 mL/min
- Haemoglobin (Hb) outside of the normal range
- Platelet count <125 x 109/L
- Serum potassium outside of the normal range
- White blood cell (WBC) count outside of the normal range
- Thyroid stimulating hormone (TSH) outside of the normal range
- Any other clinically significant abnormal lab values, as determined by the
Clinical Investigator.
6. Subjects who smoke or who have smoked at all in the past 3 months.
7. Positive pregnancy test at Screening or Baseline.
8. History of any medically significant condition considered by the Investigator to
adversely affect participation in the trial.
9. Non-compliance with a gluten free diet or flare in coeliac disease symptoms from
Screening to Baseline.
10. Clinically relevant abnormality on ECGs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
34
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Q-Pharm Pty Ltd - Herston
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Recruitment hospital [2]
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Nucleus Network - Centre for Clinical Studies - Melbourne
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nexpep Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to determine the safety of weekly injections of Nexvax2
given for three weeks to patients with coeliac disease who have been on a gluten-free diet.
The second purpose of this study is to compare the immune response over the three week study
period in coeliac disease patients given Nexvax2 compared to those given saline.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00879749
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gregor Brown, MBBS PhD FRACP
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Address
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The Alfred Hospital, Victoria
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00879749
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