Hepatitis C, ChronicPEGIMPACTNCT00704756
An Observational Study of Patients With Chronic Hepatitis C Undergoing Treatment With PegIntron and Rebetol in Clinical Practice in Belgium (Study P05494)(WITHDRAWN)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Who may be able to join
- Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.
- For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).
- Subjects must be free of any clinically significant disease that would interfere with study participation.
Who cannot join
- For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.
About this study
Official title: An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- PEGIMPACT
This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegIntron (peginterferon alfa-2b; SCH 54031)Biological
Also called SCH 54031
PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered based on body weight 800-1200 mg/day (<65 kg : 800 mg, 65 - 85 kg : 1000 mg, >85 kg : 1200 mg) orally for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium. Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications
Measured: Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment.
Secondary outcomes (2)
Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters
Measured: Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment
Predictors of response at End-of-Treatment
Measured: Assessed at the End-of-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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
- Enrolment
- 0 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
- NCT00704756
- Sponsor's protocol ID
- P05494
- Acronym
- PEGIMPACT
- Status last verified
- Aug 2014
- First submitted
- 23 Jun 2008
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Golstein P, Mulkay JP, Van Steenbergen W, Yap P, Nevens F, Denys AM, Brasseur JP. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust study. Acta Gastroenterol Belg. 2010 Jan-Mar;73(1):5-11.
PubMed 20458844
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multi-Center Study Exploring the Association of Safety, Patient Characteristics, Virological, and Histological Parameters With Patient Outcome (Relapse Rate, Achievement of Sustained Viral Response in Daily Clinical Practice in Belgium- PEGIMPACT
- ClinicalTrials.gov ID
- NCT00704756
- Acronym / sponsor ID
- PEGIMPACT / P05494
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Jun 2008 (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.
This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
Key inclusion criteria (5 listed)
- Male and female adult (18 years or older) subjects for whom the treating physician has decided to start treatment with PegIntron® and Rebetol® and reaching the End-of-Treatment time point.
- For the prospective component, evidence of treatment response at EOT after a complete course of therapy as per SmPC.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be diagnosed with chronic hepatitis C (genotypes 1, 2, 3, 4, 5 or 6).
- Subjects must be free of any clinically significant disease that would interfere with study participation.
Key exclusion criteria (1 listed)
- For prospective component of the study: patients not achieving End-of-Treatment response after a complete course of therapy as per SmPC.
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 |
|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031)Also: SCH 54031PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) | Biological | Arm 1 |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered based on body weight 800-1200 mg/day (<65 kg : 800 mg, 65 - 85 kg : 1000 mg, >85 kg : 1200 mg) orally for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) | Drug | Arm 1 |
Primary outcome
Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications
Time frame: Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment.
2 secondary outcomes
Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters
Time frame: Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment
Predictors of response at End-of-Treatment
Time frame: Assessed at the End-of-Treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Results publication: PubMed 20458844Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Golstein P, Mulkay JP, Van Steenbergen W, Yap P, Nevens F, Denys AM, Brasseur JP. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust study. Acta Gastroenterol Belg. 2010 Jan-Mar;73(1):5-11.
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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, Chronic and Hepatitis C, 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 5 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: withdrawn, as of the sponsor's last update on 11 Aug 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications (time frame: Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment.). 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 NCT00704756, 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 11 Aug 2014.