Hepatitis CNCT00724451
Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
An observational study of Hepatitis C and Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2b, Ribavirin and Peginterferon alfa-2a
- How many people
- 1,128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Oct 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Consecutive adult patients with chronic hepatitis C seen in common clinical practice at approximately 54 sites in Italy. Treatment for hepatitis C is determined at the local site (pegylated interferon a or b/ribavirin).
Who may be able to join
- Willingness to sign an Informed Consent
- Male and female patients >=18 years of age with Chronic Hepatitis C
- Not previously treated with Peg-Interferons
- Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)
Who cannot join
- Previous treatment with peginterferon
- Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start
About this study
Official title: Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.
Read the detailed description
Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2b, Ribavirin, Peginterferon alfa-2a
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bBiological
Also called SCH 054031, PegIntron
Peginterferon alfa-2b administered in accordance with approved labeling
RibavirinDrug
Also called SCH 018908, Copegus, Rebetol, Virazole
Ribavirin administered in accordance with approved labeling
Peginterferon alfa-2aBiological
Also called Pegasys
Peginterferon alfa-2a administered in accordance with approved labeling
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Hepatitis C (CHC) | Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin. Receives: Biological: Peginterferon alfa-2b; Drug: Ribavirin; Biological: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
Measured: Measured at baseline
Secondary outcomes (2)
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Investigators recorded reasons for treatment discontinuation.
Measured: 24 weeks after the end of treatment (total of 48 to 72 weeks)
Number of Participants With Treatment Failure by Reason for Failure
Investigators recorded reasons for treatment failure whether or not treatment was completed.
Measured: 24 to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724451
- Sponsor's protocol ID
- P05488
- Status last verified
- Sep 2015
- First submitted
- 25 Jul 2008
- Last updated
- 25 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis. 2015 Feb;47(2):151-6. doi: 10.1016/j.dld.2014.11.002. Epub 2014 Nov 13.
PubMed 25483909
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice
- ClinicalTrials.gov ID
- NCT00724451
- Acronym / sponsor ID
- P05488
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 31 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.
Detailed description
Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Chronic Hepatitis C (CHC) | – | Biological: Peginterferon alfa-2b, Drug: Ribavirin, Biological: Peginterferon alfa-2aPeginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients with chronic hepatitis C seen in common clinical practice at approximately 54 sites in Italy. Treatment for hepatitis C is determined at the local site (pegylated interferon a or b/ribavirin).
Key inclusion criteria (4 listed)
- Willingness to sign an Informed Consent
- Male and female patients >=18 years of age with Chronic Hepatitis C
- Not previously treated with Peg-Interferons
- Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)
Key exclusion criteria (2 listed)
- Previous treatment with peginterferon
- Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start
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-2bAlso: SCH 054031, PegIntronPeginterferon alfa-2b administered in accordance with approved labeling | Biological | Participants with Chronic Hepatitis C (CHC) |
| RibavirinAlso: SCH 018908, Copegus, Rebetol, VirazoleRibavirin administered in accordance with approved labeling | Drug | Participants with Chronic Hepatitis C (CHC) |
| Peginterferon alfa-2aAlso: PegasysPeginterferon alfa-2a administered in accordance with approved labeling | Biological | Participants with Chronic Hepatitis C (CHC) |
Primary outcome
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility
Time frame: Measured at baseline
Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.
2 secondary outcomes
Number of Participants Discontinued From Treatment by Reason for Discontinuation
Time frame: 24 weeks after the end of treatment (total of 48 to 72 weeks)
Number of Participants With Treatment Failure by Reason for Failure
Time frame: 24 to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25483909Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis. 2015 Feb;47(2):151-6. doi: 10.1016/j.dld.2014.11.002. Epub 2014 Nov 13.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
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 2 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 31 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility (time frame: Measured at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724451, which also lists 1 linked publication.
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 25 Sep 2015.