Pre-EclampsiaPhase 1NCT00333307
Evaluation of the Safety of Relaxin in Preeclampsia
A Phase 1 study testing recombinant human relaxin in people with Pre-Eclampsia, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- recombinant human relaxin
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to not given
- Phase
- Phase 1
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of preeclampsia
- Hospital admission for expectant management
Who cannot join
- Eclampsia or history of seizures
- Vaginal bleeding
- Multifetal gestation
- Requirement for immediate delivery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Central Baptist Hospital
Lexington, Kentucky, 40503
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia
Read the detailed description
The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.
- Conditions
- Pre-Eclampsia
- Being tested
- recombinant human relaxin
- Keywords
- relaxin, preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human relaxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences
Secondary outcomes (4)
preeclampsia assessments
vital signs
physical examinations
clinical laboratory assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sam Teichman, MD, Study director, Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333307
- Sponsor's protocol ID
- RLX.PE.001
- Status last verified
- Mar 2010
- First submitted
- 1 Jun 2006
- Last updated
- 16 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia
- ClinicalTrials.gov ID
- NCT00333307
- Acronym / sponsor ID
- RLX.PE.001
- Conditions
- Pre-Eclampsia
- Keywords
- relaxin, preeclampsia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 5 Jun 2006 (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 purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia
Detailed description
The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of preeclampsia
- Hospital admission for expectant management
Key exclusion criteria (4 listed)
- Eclampsia or history of seizures
- Vaginal bleeding
- Multifetal gestation
- Requirement for immediate delivery
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 |
|---|---|---|
| recombinant human relaxin | Drug | – |
Primary outcome
maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences
4 secondary outcomes
preeclampsia assessments
vital signs
physical examinations
clinical laboratory assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Sam Teichman, MD study director
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant human relaxin in people with Pre-Eclampsia, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 2 sites 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 2 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: paused, as of the sponsor's last update on 16 Mar 2010. 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 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
maternal adverse experiences. The study lists 3 primary outcomes in all. 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 16 Mar 2010.