HeparinPhase 1NCT03113084
Study With Heparin Sodium in Subcutaneous Administration
A Phase 1 study testing Sodium Heparin UQ subcutaneous drug administration and Sodium Heparin FK subcutaneous drug administration in people with Heparin, run by União Química Farmacêutica Nacional S/A at 1 site in Brazil.
Trial summary
The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heparin
- What is being tested?
- Sodium Heparin UQ subcutaneous drug administration and Sodium Heparin FK subcutaneous drug administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2022to 10 Oct 2023
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible healthy participants should sign the Informed Consent Form,
- be between 18 and 60 years of age,
- be male,
- present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
- be characterized as a voluntary (Normal physical examination)
- no history of current or recent diseases.
Who cannot join
- hemoglobin <12 g / dL;
- Platelets <100 x 109 / L;
- Regular or last 30 days use of anticoagulant medications;
- Current or past use of anti-inflammatory or anti-platelet medications;
- History of gastrointestinal bleeding;
- History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
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- Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
- serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
- Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
- Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
- donation of blood (> 500 mL) in the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants
The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.
Read the detailed description
This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.
Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.
- Conditions
- Heparin
- Being tested
- Sodium Heparin UQ subcutaneous drug administration, Sodium Heparin FK subcutaneous drug administration
- Keywords
- Sodium Heparin, Pharmacokinetics, Coagulation factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Heparin UQ subcutaneous drug administrationBiological
The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
Sodium Heparin FK subcutaneous drug administrationBiological
The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
| Study group | Role | What they receive |
|---|---|---|
| Group Sodium Heparin UQ First | Experimental | The participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period Receives: Biological: Sodium Heparin UQ subcutaneous drug administration; Biological: Sodium Heparin FK subcutaneous drug administration |
| Group Sodium Heparin FK First | Experimental | The participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period Receives: Biological: Sodium Heparin UQ subcutaneous drug administration; Biological: Sodium Heparin FK subcutaneous drug administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of the anti-Xa factor
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
Measured: 8 hours
Secondary outcomes (4)
Activity of anti-IIa factor
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
Measured: 8 hours
activity of anti-Xa / anti-IIa ratio
the calculated ratio of the activity of anti-Xa / anti-IIa
Measured: 8 hours
activity of tissue factor pathway activity (TFPI)
the Elisa assay will determine the activity of tissue factor pathway activity (TFPI)
Measured: 8 hours
adverse events
Adverse events occurred in the study
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start20 Aug 2022 (estimated)
- Primary completion20 Apr 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Why it stopped: Delay in the R\&D stage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeparinStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Hospitalizations for administration of study medications will occur in two periods (visits 1 and 2) for administration of the drugs, and participants who receive the test medication at visit 1 will receive the comparator medication at Visit 2 and vice versa.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- União Química Farmacêutica Nacional S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
- Responsible party
- Sponsor
- Investigators
- Paula F Santos, Study director, União Química Farmacêutica Nacional S/A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113084
- Sponsor's protocol ID
- PGUQ003
- Status last verified
- Jun 2019
- First submitted
- 29 Mar 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants
- ClinicalTrials.gov ID
- NCT03113084
- Acronym / sponsor ID
- PGUQ003
- Conditions
- Heparin
- Keywords
- Sodium Heparin, Pharmacokinetics, Coagulation factor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Delay in the R\&D stage
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- União Química Farmacêutica Nacional S/AIndustry (pharma, biotech, devices)
- Collaborators
- Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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 phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.
Detailed description
This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.
Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hospitalizations for administration of study medications will occur in two periods (visits 1 and 2) for administration of the drugs, and participants who receive the test medication at visit 1 will receive the comparator medication at Visit 2 and vice versa.
| Arm | Type | Receives |
|---|---|---|
| Group Sodium Heparin UQ First | Experimental | Biological: Sodium Heparin UQ subcutaneous drug administration, Biological: Sodium Heparin FK subcutaneous drug administrationThe participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period |
| Group Sodium Heparin FK First | Experimental | Biological: Sodium Heparin UQ subcutaneous drug administration, Biological: Sodium Heparin FK subcutaneous drug administrationThe participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Eligible healthy participants should sign the Informed Consent Form,
- be between 18 and 60 years of age,
- be male,
- present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
- be characterized as a voluntary (Normal physical examination)
Key exclusion criteria (11 listed)
- hemoglobin <12 g / dL;
- Platelets <100 x 109 / L;
- Regular or last 30 days use of anticoagulant medications;
- Current or past use of anti-inflammatory or anti-platelet medications;
- History of gastrointestinal bleeding;
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 |
|---|---|---|
| Sodium Heparin UQ subcutaneous drug administrationThe participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas | Biological | Group Sodium Heparin FK First, Group Sodium Heparin UQ First |
| Sodium Heparin FK subcutaneous drug administrationThe participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas | Biological | Group Sodium Heparin FK First, Group Sodium Heparin UQ First |
Primary outcome
Activity of the anti-Xa factor
Time frame: 8 hours
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
4 secondary outcomes
Activity of anti-IIa factor
Time frame: 8 hours
activity of anti-Xa / anti-IIa ratio
Time frame: 8 hours
activity of tissue factor pathway activity (TFPI)
Time frame: 8 hours
adverse events
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Paula F Santos study director
União Química Farmacêutica Nacional S/A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Heparin UQ subcutaneous drug administration and Sodium Heparin FK subcutaneous drug administration in people with Heparin, run by União Química Farmacêutica Nacional S/A 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 6 inclusion and 11 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 14 Oct 2019. 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 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?
Activity of the anti-Xa factor (time frame: 8 hours). 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 14 Oct 2019.