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| Sponsor: | Nexpep Pty Ltd |
|---|---|
| Information provided by: | Nexpep Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00879749 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coeliac Disease Celiac Disease |
Biological: 9 micrograms Nexvax2 Biological: 30 micrograms Nexvax2 Biological: 90 micrograms Nexvax2 Biological: 60 micrograms Nexvax2 Biological: Up to 900 micrograms Nexvax2 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
| Enrollment: | 34 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Saline |
Other: Placebo
100 microlitres 0.9% sterile sodium chloride for injection
|
| Experimental: Nexvax2 |
Biological: 9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration
Biological: 30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration
Biological: 90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration
Biological: 60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration
Biological: Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Have coeliac disease meeting the following criteria:
Key Exclusion Criteria:
Any of the following laboratory abnormalities at Screening:
Contacts and Locations| Australia, Queensland | |
| Q-Pharm Pty Ltd | |
| Herston, Queensland, Australia, 4006 | |
| Australia, Victoria | |
| Nucleus Network - Centre for Clinical Studies | |
| Melbourne, Victoria, Australia, 3004 | |
| Principal Investigator: | Gregor Brown, MBBS PhD FRACP | The Alfred Hospital, Victoria |
| Principal Investigator: | James Daveson, MBBS FRACP | Princess Alexandra Hospital, Queensland |
More Information
| Responsible Party: | Robert Anderson/Chief Executive Officer, Nexpep Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00879749 History of Changes |
| Other Study ID Numbers: | Nexvax2-001 |
| Study First Received: | April 8, 2009 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |