ThrombusPhase 3HEPHIP0509NCT00914472
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
A Phase 3 study testing heparin sodium - APP and Heparin sodium - Hipolabor in people with Thrombus, run by Azidus Brasil at 1 site in Brazil.
Trial summary
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombus
- What is being tested?
- heparin sodium - APP and Heparin sodium - Hipolabor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Mar 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Research that patients agreed to participate and signed the written informed consent;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.
Who cannot join
- Hypersensitivity to heparin sodium and / or benzyl alcohol;
- History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
- Severe liver disease;
- Cancer;
- Period of gestation;
- Genetic abnormality of the coagulation system;
Show all 13Show fewer
- Multiple trauma;
- Use of aspirin in high doses (above 200mg per day);
- Use of glucocorticoids for at least 1 month;
- Use of other anticoagulants;
- Submission of a big surgery done less than 15 days;
- History of persistent hypertension at the end of dialysis than 150/100 mmHg;
- Indicated doses of heparin 20% above or below 150UI/kg.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
Official title: A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin
- Conditions
- Thrombus
- Being tested
- heparin sodium - APP, Heparin sodium - Hipolabor
- Keywords
- Preventing the thrombi formation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin sodium - APPBiological
Heparin 5000 IU / mL
Heparin sodium - HipolaborBiological
Heparin 5000 IU / mL
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Heparin - Hipolabor Receives: Biological: Heparin sodium - Hipolabor |
| Ative comparator | Active comparator | Heparin - APP Receives: Biological: heparin sodium - APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of heparin in thrombi formation.
During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.
Measured: 12 consecutive sessions
Secondary outcomes (2)
Alteration of the pharmacodynamic parameters.
During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
Measured: 12 consecutive sessions.
Evaluation of Anti-Xa
Measured: 12 consecutive sessions (4 weeks - 3times/week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startApr 2010
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914472
- Sponsor's protocol ID
- HEPHIP0509
- Other IDs
- Version 01
- Acronym
- HEPHIP0509
- Status last verified
- Dec 2009
- First submitted
- 4 Jun 2009
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT00914472
- Acronym / sponsor ID
- HEPHIP0509 / HEPHIP0509
- Conditions
- Thrombus
- Keywords
- Preventing the thrombi formation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (estimated)
- First posted
- 5 Jun 2009 (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.
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Biological: Heparin sodium - HipolaborHeparin - Hipolabor |
| Ative comparator | Active comparator | Biological: heparin sodium - APPHeparin - APP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Research that patients agreed to participate and signed the written informed consent;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.
Key exclusion criteria (13 listed)
- Hypersensitivity to heparin sodium and / or benzyl alcohol;
- History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
- Severe liver disease;
- Cancer;
- Period of gestation;
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 |
|---|---|---|
| heparin sodium - APPHeparin 5000 IU / mL | Biological | Ative comparator |
| Heparin sodium - HipolaborHeparin 5000 IU / mL | Biological | Test |
Primary outcome
Effectiveness of heparin in thrombi formation.
Time frame: 12 consecutive sessions
During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.
2 secondary outcomes
Alteration of the pharmacodynamic parameters.
Time frame: 12 consecutive sessions.
Evaluation of Anti-Xa
Time frame: 12 consecutive sessions (4 weeks - 3times/week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
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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 Phase 3 study testing heparin sodium - APP and Heparin sodium - Hipolabor in people with Thrombus, run by Azidus Brasil at 1 site 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 13 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 27 Oct 2010. 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 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?
Effectiveness of heparin in thrombi formation. (time frame: 12 consecutive sessions). 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 27 Oct 2010.