Pregnancy; Fetomaternal HemorrhagePhase 3NCT01666249
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.
A Phase 3 study testing Immunoglobulin Anti-RhD in people with Pregnancy; Fetomaternal Hemorrhage, run by Azidus Brasil at 5 sites in Brazil.
Trial summary
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy; Fetomaternal Hemorrhage
- What is being tested?
- Immunoglobulin Anti-RhD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 5 sitesBrazil
- Study dates
- Apr 2014to Dec 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to participate, sign and date ICF;
- 18 years old or older;
- Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby.
Who cannot join
- Be participating simultaneously or have participated in another clinical trial within the last 12 months;
- Mothers who are allergic to any components of the formula;
- Mothers who have a history of IgA deficiency or IgA antibody present;
- Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis;
- Mothers who have indirect Coombs test positive at the beginning of the treatment;
- Rh-negative mothers whose delivered Rh-negative babies;
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- Abnormalities of the coagulation system;
- Patients who made use of vaccines made with live pathogens in the last 03 months or will make during the study;
- Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;
- Principal Investigator of the study criteria.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Associação Educadora São Carlos AESC - Centro de Pesquisa HRPC
Canoas, Rio Grande do Sul, 92425-900
Instituto Tropical de Medicina Reprodutiva e Menopausa -INTRO
Cuiabá, Mato Grosso, 78043-306
Centro de Pesquisa da MEAC - Maternidade Escola Assis Chateaubriand
Fortaleza, Ceará, 60430-270
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital São Lucas (Puc-Rs)
Porto Alegre, Rio Grande do Sul, 90610-000
About this study
Official title: Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).
Read the detailed description
This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until six months to verification of negative Coombs maintenance. Safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).
- Conditions
- Pregnancy; Fetomaternal Hemorrhage
- Being tested
- Immunoglobulin Anti-RhD
- Keywords
- FMH; anti-Rh; efficacy
- Medical subject headings
- Fetomaternal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin Anti-RhDBiological
Also called KamRho-D
Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).
| Study group | Role | What they receive |
|---|---|---|
| Immunoglobulin Anti-RhD | Experimental | Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth). Receives: Biological: Immunoglobulin Anti-RhD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative result for coombs test up to six months after immunization
Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.
Measured: up to six months
Secondary outcomes (1)
Adverse Events Report
Safety of human immunoglobulin anti-RhD will be verified through adverse events reported by participants throughout study. The adverse events will be classified about the type, frequency, intensity, seriousness, severity and relation to the study drug.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionDec 2020
Why it stopped: Suspended for indetermined period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy; Fetomaternal HemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Panamerican Medical Supply
- Responsible party
- Sponsor
- Investigators
- Regina M Doi, physician, Study director, Azidus Brasil Scientific Research and Development Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666249
- Sponsor's protocol ID
- IMUPAN1011
- Other IDs
- Emenda 3.0 - 19/09/2017
- Status last verified
- Nov 2022
- First submitted
- 25 Jul 2012
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.
- ClinicalTrials.gov ID
- NCT01666249
- Acronym / sponsor ID
- IMUPAN1011
- Conditions
- Pregnancy; Fetomaternal Hemorrhage
- Keywords
- FMH; anti-Rh; efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended for indetermined period.
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Panamerican Medical Supply
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2020
- First posted
- 16 Aug 2012 (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 a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).
Detailed description
This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until six months to verification of negative Coombs maintenance. Safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoglobulin Anti-RhD | Experimental | Biological: Immunoglobulin Anti-RhDParticipants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agree to participate, sign and date ICF;
- 18 years old or older;
- Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby.
Key exclusion criteria (10 listed)
- Be participating simultaneously or have participated in another clinical trial within the last 12 months;
- Mothers who are allergic to any components of the formula;
- Mothers who have a history of IgA deficiency or IgA antibody present;
- Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis;
- Mothers who have indirect Coombs test positive at the beginning of the treatment;
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 |
|---|---|---|
| Immunoglobulin Anti-RhDAlso: KamRho-DParticipants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth). | Biological | Immunoglobulin Anti-RhD |
Primary outcome
Negative result for coombs test up to six months after immunization
Time frame: up to six months
Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.
1 secondary outcome
Adverse Events Report
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy; Fetomaternal Hemorrhage
Not yet recruitingObservational study
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
Hemolytic Disease of the Newborn
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.
Regina M Doi, physician study director
Azidus Brasil Scientific Research and Development Ltda
5 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 Immunoglobulin Anti-RhD in people with Pregnancy; Fetomaternal Hemorrhage, run by Azidus Brasil at 5 sites in Brazil.
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 10 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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?
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?
Negative result for coombs test up to six months after immunization (time frame: up to six months). 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 2 Nov 2022.