Hepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedNCT00514111
Factors Associated to Success of Hepatitis C Therapy
An observational study of Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
- What is being tested?
- pegylated-interferon, conventional-interferon, ribavirin
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Dec 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HVC patients attended in SAE e HD.
Who may be able to join
- HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin
Who cannot join
- No HVC infection or treatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.
Read the detailed description
Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.
- Being tested
- pegylated-interferon, conventional-interferon, ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated-interferon, conventional-interferon, ribavirinDrug
Also called Pegasys, PegIntron, Ribavirin
Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HVC Patients | HVC patients attended in SAE e HD. Receives: Drug: pegylated-interferon, conventional-interferon, ribavirin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre N Barbosa, MD, MSc, Principal investigator, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514111
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-16
- Status last verified
- Mar 2009
- First submitted
- 8 Aug 2007
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated to Success of Hepatitis C Therapy
- ClinicalTrials.gov ID
- NCT00514111
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-16
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Aug 2007 (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 of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.
Detailed description
Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HVC Patients | – | Drug: pegylated-interferon, conventional-interferon, ribavirinHVC patients attended in SAE e HD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HVC patients attended in SAE e HD.
Key inclusion criteria (1 listed)
- HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin
Key exclusion criteria (1 listed)
- No HVC infection or 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 |
|---|---|---|
| pegylated-interferon, conventional-interferon, ribavirinAlso: Pegasys, PegIntron, RibavirinGenotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks. | Drug | HVC Patients |
Primary outcome
Not reported in the source record.
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 20 Mar 2009.
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 N Barbosa, MD, MSc principal investigator
UPECLIN HC FM Botucatu Unesp
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 Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, run by UPECLIN HC FM Botucatu Unesp 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 1 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: finished, as of the sponsor's last update on 20 Mar 2009. 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.
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 20 Mar 2009.