Hepatitis C, ChronicOPTIMNCT01884402
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4
An observational study of Hepatitis C, Chronic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
Trial summary
Primary objective: Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- How many people
- 770 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2010to Aug 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.
Who may be able to join
- Patients with > 18 years old.
- Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
- Patients Genotype 1 and 4.
- Patients with the results of all the factors evaluable at the time of inclusion.
- Patients who have accepted their participation in the study through informed consent.
Who cannot join
- Patients previously treated with interferon (IFN) and ribavirin (RBV).
- Patients with genotype 2, 3, 5 and 6.
- Patients with co-infection with hepatitis B.
- Patients with other liver diseases.
- Patients with any contraindications to the drugs used in the treatment of hepatitis C.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville, Sevilla
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville
About this study
Official title: Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.
Primary objective:
- Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Read the detailed description
This Tool:
- Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
- Identify those patients most likely to respond.
- Therapy and therefore optimize resources
The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
Also called Pegasys
Treatment as usual clinical practice
RibavirinDrug
Also called Copegus
Treatment as usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Pegasys, injection subcutaneous | HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (RVS)
Measurement of HCV RNA negativization 24 weeks after treatment
Measured: 1 ½ years (72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startOct 2010
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Romero-Gómez, Medicine, Principal investigator, Hospital de Valme & ciberEHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884402
- Sponsor's protocol ID
- FPS-PEG-2010-01
- Acronym
- OPTIM
- Status last verified
- Sep 2014
- First submitted
- 18 Jun 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.
- ClinicalTrials.gov ID
- NCT01884402
- Acronym / sponsor ID
- OPTIM / FPS-PEG-2010-01
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jun 2013 (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.
Primary objective:
- Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.
Detailed description
This Tool:
- Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
- Identify those patients most likely to respond.
- Therapy and therefore optimize resources
The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegasys, injection subcutaneous | – | Drug: Peginterferon alfa-2a, Drug: RibavirinHCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C genotype 1 and 4 mono-or co-infected with HIV who meet the selection criteria described.
Key inclusion criteria (5 listed)
- Patients with > 18 years old.
- Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
- Patients Genotype 1 and 4.
- Patients with the results of all the factors evaluable at the time of inclusion.
- Patients who have accepted their participation in the study through informed consent.
Key exclusion criteria (5 listed)
- Patients previously treated with interferon (IFN) and ribavirin (RBV).
- Patients with genotype 2, 3, 5 and 6.
- Patients with co-infection with hepatitis B.
- Patients with other liver diseases.
- Patients with any contraindications to the drugs used in the treatment of hepatitis C.
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysTreatment as usual clinical practice | Drug | Pegasys, injection subcutaneous |
| RibavirinAlso: CopegusTreatment as usual clinical practice | Drug | Pegasys, injection subcutaneous |
Primary outcome
Sustained Viral Response (RVS)
Time frame: 1 ½ years (72 weeks)
Measurement of HCV RNA negativization 24 weeks after treatment
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 4 Sep 2014.
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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.
Manuel Romero-Gómez, Medicine principal investigator
Hospital de Valme & ciberEHD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
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 5 inclusion and 5 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Sustained Viral Response (RVS) (time frame: 1 ½ years (72 weeks)). 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 4 Sep 2014.