Drug HypersensitivityPhase 3DRESS2NCT00505648
Treatment of Hypersensitivity Syndrome (DRESS) With Tegeline® (Human Immunoglobulin)
A Phase 3 study testing Tegeline® in people with Drug Hypersensitivity, run by University Hospital, Rouen at 2 sites in France.
Trial summary
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Tegeline®
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18
- Cutaneous and/or mucous eruption
- Polyadenopathy
- Body temperature > 38°C
- Hematology disorders : Hypereosinophily > 1.5 G/l, lymphocytosis > 5G/l, atypical blood lymphocytes
- Consent obtained from patient
Who cannot join
- Age < 18
- No consent obtained from patient
- IgV allergy
- Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
- Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
- IgA deficiency,
- MCI >=35
- Sharp renal insufficiency before Dress with creatinaemia < 60 ml/min (Cockroft)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.
- Conditions
- Drug Hypersensitivity
- Being tested
- Tegeline®
- Keywords
- Hypersensitivity, Syndrome, Tegeline
- Medical subject headings
- Drug Hypersensitivity, Hypersensitivity, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegeline®Drug
2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old.
What is being measured
The primary outcome is the main question the study is designed to answer.
express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype
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 Jul 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Side effects valuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal JOLY, MD-PHD, Principal investigator, Clinique Dermatologique - Hôpital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505648
- Sponsor's protocol ID
- 2004/077/HP
- Acronym
- DRESS2
- Status last verified
- Mar 2015
- First submitted
- 20 Jul 2007
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of DRESS (Drug Reaction With Eosinophilia and Systemic Symptoms) With Tegeline®
- ClinicalTrials.gov ID
- NCT00505648
- Acronym / sponsor ID
- DRESS2 / 2004/077/HP
- Conditions
- Drug Hypersensitivity
- Keywords
- Hypersensitivity, Syndrome, Tegeline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Side effects valuation
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Jul 2007 (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.
Efficacy and tolerance of Tegeline® treatment in hypersensitivity syndrome. Immunological study of the T cell index phenotype and functionality in hypersensitivity syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18
- Cutaneous and/or mucous eruption
- Polyadenopathy
- Body temperature > 38°C
- Hematology disorders : Hypereosinophily > 1.5 G/l, lymphocytosis > 5G/l, atypical blood lymphocytes
Key exclusion criteria (8 listed)
- Age < 18
- No consent obtained from patient
- IgV allergy
- Dress with very sérious visceral attack and vital diagnostic (sharp cardiac insufficiency, sharp respiratory insufficiency, hepatic insufficiency, sharp renal insufficiency)
- Oral therapy or immunosuppressive therapy (Methotrexate, cyclosporine, cyclophosphamide, etc.)
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 |
|---|---|---|
| Tegeline®2g/kg in IV on 2days 2g/kg in IV on 4days for patients with renal insufficiency or 65 years old. | Drug | – |
Primary outcome
express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Side effects valuation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
Pascal JOLY, MD-PHD principal investigator
Clinique Dermatologique - Hôpital Charles Nicolle
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegeline® in people with Drug Hypersensitivity, run by University Hospital, Rouen at 2 sites in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Side effects valuation). Results are not available in the source record.
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?
express healing of visceral attacks, healing of polyadenopathy and body temperature, biological abnormal values normalisation, express healing of cutaneous and mucous diseases immunological study of the T cell index phenotype (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 24 Mar 2015.