Shiga-like Toxin-producing Escherichia ColiPhase 2/3STEC-HUSNCT01410916
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
A Phase 2/3 study testing Eculizumab (Soliris®) in people with Shiga-like Toxin-producing Escherichia Coli, run by Alexion Pharmaceuticals, Inc. at 22 sites in Germany.
Trial summary
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Shiga-like Toxin-producing Escherichia Coli
- What is being tested?
- Eculizumab (Soliris®)
- Type of treatment
- Injection or infusion
- How many people
- 198 participants
- Where
- 22 sitesGermany
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 2/3
- 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 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must be willing and able to give written informed consent/Assent.
- Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
- Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Who cannot join
- Known complement regulatory mutation or family history of complement regulatory mutation
- Unresolved systemic meningococcal disease
- 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Study site
Bielefeld, 33615
Study site
Bielefeld, 33617
Study site
Bonn, 53127
Study site
Bremen, 28177
Study site
Bremerhaven, 27574
Study site
Cologne, 50937
Study site
Essen, 45147
Study site
Flensburg, 24939
Study site
Göttingen, 37075
Study site
Hamburg, 20246
Study site
Hamburg, 22291
Study site
Hamburg, 22359
Study site
Hanover, 30625
Study site
Karlsruhe, 76133
Study site
Lübeck, 23538
Study site
Magdeburg, 39120
Study site
München, 81377
Study site
Munich, 80804
Study site
Münster, 48149
Study site
Oldenburg, 26133
Study site
Ulm, 89081
Study site
Wildeshausen, 27793
About this study
Official title: An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.
- Being tested
- Eculizumab (Soliris®)
- Keywords
- STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eculizumab (Soliris®)Drug
Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis
Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shiga-like Toxin-producing Escherichia ColiStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410916
- Sponsor's protocol ID
- C11-001
- Other IDs
- 2011-002691-17
- Acronym
- STEC-HUS
- Status last verified
- Apr 2013
- First submitted
- 3 Aug 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
- ClinicalTrials.gov ID
- NCT01410916
- Acronym / sponsor ID
- STEC-HUS / C11-001
- Keywords
- STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Aug 2011 (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.
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be willing and able to give written informed consent/Assent.
- Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
- Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
Key exclusion criteria (3 listed)
- Known complement regulatory mutation or family history of complement regulatory mutation
- Unresolved systemic meningococcal disease
- 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
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 |
|---|---|---|
| Eculizumab (Soliris®)Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously | Drug | – |
Primary outcome
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis
Time frame: 8 weeks
Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder.
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 5 Apr 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eculizumab (Soliris®) in people with Shiga-like Toxin-producing Escherichia Coli, run by Alexion Pharmaceuticals, Inc. at 22 sites in Germany.
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 3 inclusion and 3 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 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis (time frame: 8 weeks). 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 5 Apr 2013.