Hemoglobinuria, ParoxysmalEMBRACENCT00438789
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
A study testing eculizumab in people with Hemoglobinuria, Paroxysmal, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoglobinuria, Paroxysmal
- What is being tested?
- eculizumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- PNH;
- At least 18 years old
- Avoid conception; and
- Willing and able to give written informed consent
Who cannot join
- Active bacterial infection
- Participation in any other drug trial
- Pregnant breast feeding, or intending to conceive
- Not vaccinated against N meningitidis
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
- Conditions
- Hemoglobinuria, Paroxysmal
- Being tested
- eculizumab
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eculizumabDrug
600mg IV every week and 900mg IV every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemoglobinuria, ParoxysmalStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438789
- Sponsor's protocol ID
- C06-002
- Acronym
- EMBRACE
- Status last verified
- Sep 2011
- First submitted
- 20 Feb 2007
- Last updated
- 6 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
- ClinicalTrials.gov ID
- NCT00438789
- Acronym / sponsor ID
- EMBRACE / C06-002
- Conditions
- Hemoglobinuria, Paroxysmal
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 22 Feb 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.
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PNH;
- At least 18 years old
- Avoid conception; and
- Willing and able to give written informed consent
Key exclusion criteria (4 listed)
- Active bacterial infection
- Participation in any other drug trial
- Pregnant breast feeding, or intending to conceive
- Not vaccinated against N meningitidis
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 |
|---|---|---|
| eculizumab600mg IV every week and 900mg IV every 2 weeks | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Enrolling by invitationObservational study
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Not yet recruitingPhase 3
A Study of Efficacy and Safety of FXS6837 in Anti-C5 Treated PNH Patients.
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RecruitingPhase 2
Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eculizumab in people with Hemoglobinuria, Paroxysmal, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 May 2014. 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 United States. 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.
Are results available for this study?
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.
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 6 May 2014.