Hepatitis CRE-CHUTNCT00725842
Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
An observational study of Hepatitis C and Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. 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?
- Peg-IFN alfa-2b and Ribavirin
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 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: Patients with hepatitis C previously treated with Peg-IFN alfa-2b + ribavirin in common clinical practice at approximately 60 centers in France.
Who may be able to join
- The patient must demonstrate his/her continued willingness to participate in the study.
- The patient must be at least 18 years of age, of either gender.
- Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + Ribavirin as first treatment for hepatitis C.
- Negative HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.
Who cannot join
- Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry.
- Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- Patients treated for a period shorter than the enrollment period.
- Patients co-infected with human immunodeficiency virus (HIV).
- Patients co-infected with hepatitis B virus (HBV).
- Patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).
About this study
Official title: Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice
The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.
Read the detailed description
Non-probability sampling: The study population consists of adult patients over the age of 18 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be recruited in order to evaluate the objectives of the study. The patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Being tested
- Peg-IFN alfa-2b, Ribavirin
- 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.
Peg-IFN alfa-2bBiological
Also called SCH 054031
Peg-IFN alfa-2b administered in accordance with approved labeling
RibavirinDrug
Also called SCH 018908
Ribavirin administered in accordance with approved labeling
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFN alfa-2b + ribavirin | Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling). Receives: Biological: Peg-IFN alfa-2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.
Measured: 24 weeks post end of treatment (EOT)
Secondary outcomes (3)
Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment
Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.
Measured: 24 weeks post EOT
Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response
Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.
Measured: Baseline and 24 weeks post EOT
Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.
Measured: 72 weeks post EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Low enrollment
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 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
- NCT00725842
- Sponsor's protocol ID
- P05484
- Acronym
- RE-CHUT
- Status last verified
- Sep 2015
- First submitted
- 28 Jul 2008
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse Rate and Predictive Factors in the Treatment of Hepatitis C in Common Clinical Practice
- ClinicalTrials.gov ID
- NCT00725842
- Acronym / sponsor ID
- RE-CHUT / P05484
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Posted 7 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.
Detailed description
Non-probability sampling: The study population consists of adult patients over the age of 18 affected by CHC who were previously treated for the first time with Peg-IFN alfa-2b plus ribavirin and achieved end-of-treatment response. Five hundred ninety patients must be recruited in order to evaluate the objectives of the study. The patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg-IFN alfa-2b + ribavirin | – | Biological: Peg-IFN alfa-2b, Drug: RibavirinParticipants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis C previously treated with Peg-IFN alfa-2b + ribavirin in common clinical practice at approximately 60 centers in France.
Key inclusion criteria (4 listed)
- The patient must demonstrate his/her continued willingness to participate in the study.
- The patient must be at least 18 years of age, of either gender.
- Patients with chronic hepatitis C (any genotype) who received Peg-IFN alfa-2b + Ribavirin as first treatment for hepatitis C.
- Negative HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.
Key exclusion criteria (6 listed)
- Patients who completed treatment with PegInterferon Alfa-2b plus Ribavirin more than 4 weeks before study entry.
- Patients with positive HCV-RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
- Patients treated for a period shorter than the enrollment period.
- Patients co-infected with human immunodeficiency virus (HIV).
- Patients co-infected with hepatitis B virus (HBV).
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 |
|---|---|---|
| Peg-IFN alfa-2bAlso: SCH 054031Peg-IFN alfa-2b administered in accordance with approved labeling | Biological | Peg-IFN alfa-2b + ribavirin |
| RibavirinAlso: SCH 018908Ribavirin administered in accordance with approved labeling | Drug | Peg-IFN alfa-2b + ribavirin |
Primary outcome
Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
Time frame: 24 weeks post end of treatment (EOT)
HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.
3 secondary outcomes
Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment
Time frame: 24 weeks post EOT
Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response
Time frame: Baseline and 24 weeks post EOT
Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
Time frame: 72 weeks post EOT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 6 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: stopped early, as of the sponsor's last update on 21 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 7 Aug 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 With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment (time frame: 24 weeks post end of treatment (EOT)). 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 21 Sep 2015.