Fish AllergyPhase 1/2NCT02017626
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
A Phase 1/2 study testing mCyp c 1 in people with Fish Allergy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units: To establish a safe dose of the candidate hypo-allergen in human subjects and To study the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fish Allergy
- What is being tested?
- mCyp c 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
- Case history of allergy to fish ingestion.
- Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
- Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
- FEV1 at least 80% of predicted values at screening.
- Subject accepting to comply fully with the protocol.
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- For woman of child bearing potential:
- a negative urine pregnancy test at screening visit,
- subject must receive a medically effective contraceptive method during the study
Who cannot join
- Food Anaphylactic Reaction: anaphylactic shock due to fish intake.
- Specific IgE (ImmunoCAP) to fish parvalbumin (rCyp c 1) below 0.35 kUA/L
- Ongoing pollen Immunotherapy (SIT).
- Any clinical condition that contraindicates SIT (EAACI-guidelines).
- Any significant clinical condition that the investigators judged might hamper the patient's safety or the study outcomes, these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease.
- Ongoing treatment with betablockers or ACE-inhibitors.
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- Impossibility for the patient to comply with the scheduled visits.
- Pregnancy or nursing.
- Uncontrolled asthma.
- Subject who have participated in a clinical trial within 3 months prior to this one.
- Subject with a history of drug or alcohol abuse.
- Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
- Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines during screening and treatments.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units:
To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects.
The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.
Read the detailed description
The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.
- Conditions
- Fish Allergy
- Being tested
- mCyp c 1
- Keywords
- Fish allergy, immunotherapy, hypoallergen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCyp c 1Biological
Also called A modified hypo-allergenic Parvalbumin
2 patient groups with different doses of allergen.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 5 patients will receive 10 single rising doses of mCyp c 1 (modified allergen)from 0.6 ng to 6 ug and two maintenance doses, and 2 patients will receive placebo Receives: Biological: mCyp c 1 |
| Group 2 | Experimental | 6 patients will receive 10 single rising doses of mCyp c 1 from 6 ng to 60 ug and two maintenance doses, and two patients will receive placebo. Receives: Biological: mCyp c 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in the form of number and severity of adverse events
Safety is evaluated by number and severity of adverse events
Measured: 1 year
Secondary outcomes (3)
Specific IgE
To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.
Measured: 1 year
IgG4
Immunologic parameter.
Measured: 1 year
Skin Prick Test
Pharmaco-dynamics of the hypo-allergen administered to human subjects.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fish AllergyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Odense University Hospital
- Responsible party
- Principal investigator, Professor, Dr. Med Hans-Joergen Malling, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hans-Joergen Malling, MD, Principal investigator, Allergy Clinic, Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017626
- Sponsor's protocol ID
- K-489 DK
- Status last verified
- Jun 2015
- First submitted
- 21 Aug 2013
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
- ClinicalTrials.gov ID
- NCT02017626
- Acronym / sponsor ID
- K-489 DK
- Conditions
- Fish Allergy
- Keywords
- Fish allergy, immunotherapy, hypoallergen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Odense University Hospital
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units:
To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects.
The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.
Detailed description
The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: mCyp c 15 patients will receive 10 single rising doses of mCyp c 1 (modified allergen)from 0.6 ng to 6 ug and two maintenance doses, and 2 patients will receive placebo |
| Group 2 | Experimental | Biological: mCyp c 16 patients will receive 10 single rising doses of mCyp c 1 from 6 ng to 60 ug and two maintenance doses, and two patients will receive placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
- Case history of allergy to fish ingestion.
- Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
- Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
- FEV1 at least 80% of predicted values at screening.
Key exclusion criteria (13 listed)
- Food Anaphylactic Reaction: anaphylactic shock due to fish intake.
- Specific IgE (ImmunoCAP) to fish parvalbumin (rCyp c 1) below 0.35 kUA/L
- Ongoing pollen Immunotherapy (SIT).
- Any clinical condition that contraindicates SIT (EAACI-guidelines).
- Any significant clinical condition that the investigators judged might hamper the patient's safety or the study outcomes, these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCyp c 1Also: A modified hypo-allergenic Parvalbumin2 patient groups with different doses of allergen. | Biological | Group 2, group 1 |
Primary outcome
Safety in the form of number and severity of adverse events
Time frame: 1 year
Safety is evaluated by number and severity of adverse events
3 secondary outcomes
Specific IgE
Time frame: 1 year
IgG4
Time frame: 1 year
Skin Prick Test
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Joergen Malling, MD principal investigator
Allergy Clinic, Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mCyp c 1 in people with Fish Allergy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in the form of number and severity of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.