Haptoglobin TypeNCT02127385
The Type of Hepatoglobin in IUGR
An observational study of Haptoglobin Type, run by Hillel Yaffe Medical Center.
Trial summary
Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease oxidative tissue damage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Haptoglobin Type
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2015
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients adimitted with IUGR
Who may be able to join
None listed.
Who cannot join
- -
About this study
Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp 2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp 2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common and severe in the Hp 2-2 genotype with the less anti oxidant properties.
- Conditions
- Haptoglobin Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IUGR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of haptoglobin
severity of iugr
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haptoglobin TypeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- RON BELOOSESKY, M.D, Principal investigator, HILLEL YAFFE MEDICAL CENTER- TECHNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127385
- Sponsor's protocol ID
- 0001-14
- Status last verified
- Mar 2014
- First submitted
- 29 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Type of Hepatoglobin in IUGR
- ClinicalTrials.gov ID
- NCT02127385
- Acronym / sponsor ID
- 0001-14
- Conditions
- Haptoglobin Type
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 30 Apr 2014 (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.
Intra Uterine Growth Restriction is associated with increased oxidative stress. Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The function of Hp is as anti oxidant agent, it binds free hemoglobin (Hb) released from red blood cells to decrease oxidative tissue damage. There are 3 differenet genotype of haptoglobin Hp 1-1 Hp 1-2 and Hp 2-2 with different anti oxidant properties and different prevalence ( Hp 1-1, Hp 1-2 and Hp 2-2approximately 16%, 48% and 36% respectively) . we hypotheise that IUGR will be more common and severe in the Hp 2-2 genotype with the less anti oxidant properties.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IUGR | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients adimitted with IUGR
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
type of haptoglobin
Time frame: 10 weeks
severity of iugr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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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.
RON BELOOSESKY, M.D principal investigator
HILLEL YAFFE MEDICAL CENTER- TECHNION
Questions about this trial
What is this clinical trial studying?
An observational study of Haptoglobin Type, run by Hillel Yaffe Medical Center.
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 0 inclusion and 1 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 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
type of haptoglobin (time frame: 10 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 30 Apr 2014.