HealthyinterferonNCT01228422
Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A
An observational study of Healthy, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon alpha-2A - Roche Laboratory). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Interferon alpha 2a
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Aug 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Accepting the End of Free and Informed Consent;
- Research subjects were male, aged 18 to 55 years;
- Research subjects with body mass index ≥ 19 and ≤ 30;
- Be considered healthy, from the analysis of medical history, medical examination and laboratory tests within the normal range.
Who cannot join
- Results of laboratory tests outside the values considered acceptable in accordance with the criteria of medical evaluator;
- Having participated in any experimental study or have ingested any experimental drug in the last three months before the start of the study;
- Have made regular use of medication in the past 4 weeks preceding the start of the study or have made use of any medication a week before the start of the study;
- Have been hospitalized for any reason, up to 8 weeks before the start of the study;
- Present history of abuse of alcohol, drugs or medications, or have ingested alcohol within 48 hours prior to the period of stay;
- Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
- Present pressure changes of any cause that requires pharmacological treatment; present history of myocardial infarction, angina and / or heart failure;
- Have donated or lost 450 ml of blood or more in the three months preceding the study
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: Study of Pharmacokinetics and Pharmacodynamics of Alpha Interferon-2A of Blausiegel Trade and Industry the Compared the Product Roferon A, of Laboratory of Roche
The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon alpha-2A - Roche Laboratory).
Read the detailed description
The Interferons (IFNs) are a group of cytokines produced by vertebrates in response to various stimuli, including the presence of foreign nucleic acids in the body, bacteria, tumor cells and viral antigens. These proteins have significant shares immunomodulatory, antiproliferative and antiviral drugs, the first line of defense of the body. Once produced, the IFNs block viral replication, maximize the lytic activity of natural killer cells, increase the expression of MHC class I in cells infected by viruses and induce the development of Th1 cells The production of interferon alpha-2A is now held by biotechnology with the establishment of a chain of DNA producer of interferon alpha-2a in the chain of original DNA of a bacterium, allowing the bacteria produce this drug on an industrial scale. In the process of synthesis, the 165 amino acids that are part of this molecule can change in your order with no reduction in activity or changes in the properties.
Due to this fact, the biological and medicinal considered, especially those in manufacturing by genetic engineering, need to prove their clinical activity so that they can be marketed. In the case of interferon, the consequences of the use of a product without activity compared to treat patients with Hepatitis C can lead to serious health complications from them. It is therefore necessary to prove its clinical activity and pharmacokinetics before its clinical efficacy. The sponsor of this study aims to end the renewal of registration of interferon alpha-2A with the Ministry of Health So this study to evaluate the Pharmacokinetics and Pharmacodynamics of interferon alpha-2a may allow in the future this medicine can be used by a year in patients with hepatitis C, without risk to their health, besides those already known and inherent in the treatment of any interferon.
- Conditions
- Healthy
- Being tested
- Interferon alpha 2a
- Keywords
- Will be studied 24 subjects divided Research and 2 parallel groups, The treatment is a dose of 3MUI of alpha interferon 2nd, There will be collection of blood at times: 0, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours., The volunteers will be hospitalized 24 hours., Will be measured labels the AUC, Tmax, Cmax, neopterin and beta2-microglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon alpha 2aBiological
3MUI
| Study group | Role | What they receive |
|---|---|---|
| 1 | test interferon - blausiegel Receives: Biological: Interferon alpha 2a | |
| 2 | reference interferon - Roferon A (Roche) Receives: Biological: Interferon alpha 2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate in parallel pharmacodynamic parameters and pharmacokinetics.
Pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.
Measured: 96 hours.
Secondary outcomes (1)
Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events
The pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.
Measured: 96 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandre Frederico, Doctor, Principal investigator, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228422
- Sponsor's protocol ID
- INT2ABLA0908
- Acronym
- interferon
- Status last verified
- Mar 2009
- First submitted
- 21 Oct 2008
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pharmacokinetics and Pharmacodynamics of Alpha Interferon-2A of Blausiegel Trade and Industry the Compared the Product Roferon A, of Laboratory of Roche
- ClinicalTrials.gov ID
- NCT01228422
- Acronym / sponsor ID
- interferon / INT2ABLA0908
- Conditions
- Healthy
- Keywords
- Will be studied 24 subjects divided Research and 2 parallel groups, The treatment is a dose of 3MUI of alpha interferon 2nd, There will be collection of blood at times: 0, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours., The volunteers will be hospitalized 24 hours., Will be measured labels the AUC, Tmax, Cmax, neopterin and beta2-microglobulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Oct 2010 (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 aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon alpha-2A - Roche Laboratory).
Detailed description
The Interferons (IFNs) are a group of cytokines produced by vertebrates in response to various stimuli, including the presence of foreign nucleic acids in the body, bacteria, tumor cells and viral antigens. These proteins have significant shares immunomodulatory, antiproliferative and antiviral drugs, the first line of defense of the body. Once produced, the IFNs block viral replication, maximize the lytic activity of natural killer cells, increase the expression of MHC class I in cells infected by viruses and induce the development of Th1 cells The production of interferon alpha-2A is now held by biotechnology with the establishment of a chain of DNA producer of interferon alpha-2a in the chain of original DNA of a bacterium, allowing the bacteria produce this drug on an industrial scale. In the process of synthesis, the 165 amino acids that are part of this molecule can change in your order with no reduction in activity or changes in the properties.
Due to this fact, the biological and medicinal considered, especially those in manufacturing by genetic engineering, need to prove their clinical activity so that they can be marketed. In the case of interferon, the consequences of the use of a product without activity compared to treat patients with Hepatitis C can lead to serious health complications from them. It is therefore necessary to prove its clinical activity and pharmacokinetics before its clinical efficacy. The sponsor of this study aims to end the renewal of registration of interferon alpha-2A with the Ministry of Health So this study to evaluate the Pharmacokinetics and Pharmacodynamics of interferon alpha-2a may allow in the future this medicine can be used by a year in patients with hepatitis C, without risk to their health, besides those already known and inherent in the treatment of any interferon.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: Interferon alpha 2atest interferon - blausiegel |
| 2 | – | Biological: Interferon alpha 2areference interferon - Roferon A (Roche) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Accepting the End of Free and Informed Consent;
- Research subjects were male, aged 18 to 55 years;
- Research subjects with body mass index ≥ 19 and ≤ 30;
- Be considered healthy, from the analysis of medical history, medical examination and laboratory tests within the normal range.
Key exclusion criteria (8 listed)
- Results of laboratory tests outside the values considered acceptable in accordance with the criteria of medical evaluator;
- Having participated in any experimental study or have ingested any experimental drug in the last three months before the start of the study;
- Have made regular use of medication in the past 4 weeks preceding the start of the study or have made use of any medication a week before the start of the study;
- Have been hospitalized for any reason, up to 8 weeks before the start of the study;
- Present history of abuse of alcohol, drugs or medications, or have ingested alcohol within 48 hours prior to the period of stay;
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 |
|---|---|---|
| Interferon alpha 2a3MUI | Biological | 1, 2 |
Primary outcome
Evaluate in parallel pharmacodynamic parameters and pharmacokinetics.
Time frame: 96 hours.
Pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.
1 secondary outcome
Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events
Time frame: 96 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
Alexandre Frederico, Doctor principal investigator
Azidus Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate in parallel pharmacodynamic parameters and pharmacokinetics. (time frame: 96 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 26 Oct 2010.