Hepatitis C, ChronicPOMOSCHNCT01098097
Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)
An observational study of Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peginterferon alpha and Ribavirin
- How many people
- 963 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to 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: Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin
Who may be able to join
- Chronic hepatitis C of any genotype;
- Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
- Inclusion criteria listed on the approved label in each country;
- Willingness of the patient to participate and sign the Informed Consent Form.
Who cannot join
- Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.
About this study
Official title: Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin
To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
Read the detailed description
This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alpha, 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 alphaBiological
Also called PegIntron, SCH 054031, MK-4031
Peginterferon alpha given in combination with ribavirin according to local labeling guidelines
RibavirinDrug
Also called Rebetol, SCH 018908, MK-8908
Ribavirin given in combination with peginterferon alpha according to local labeling guidelines
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alpha and ribavirin | Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. Receives: Biological: Peginterferon alpha; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.
Measured: Up to 12 Weeks
Incidence of Thrombocytopenia
Thrombocytopenia is a low blood platelet count
Measured: Up to 12 Weeks
Incidence of Treatment Discontinuations Due to Adverse Events
All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.
Measured: Up to 12 Weeks
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation
All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).
The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)
Measured: Up to 12 Weeks
Incidence of Dose Modifications Due to Adverse Events
All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.
Measured: Up to 12 Weeks
Secondary outcomes (1)
Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJun 2009
- 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 963 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
- NCT01098097
- Sponsor's protocol ID
- P06011
- Acronym
- POMOSCH
- Status last verified
- Nov 2014
- First submitted
- 1 Apr 2010
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin
- ClinicalTrials.gov ID
- NCT01098097
- Acronym / sponsor ID
- POMOSCH / P06011
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
Detailed description
This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alpha and ribavirin | – | Biological: Peginterferon alpha, Drug: RibavirinPeginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin
Key inclusion criteria (4 listed)
- Chronic hepatitis C of any genotype;
- Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
- Inclusion criteria listed on the approved label in each country;
- Willingness of the patient to participate and sign the Informed Consent Form.
Key exclusion criteria (1 listed)
- Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.
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 alphaAlso: PegIntron, SCH 054031, MK-4031Peginterferon alpha given in combination with ribavirin according to local labeling guidelines | Biological | Peginterferon alpha and ribavirin |
| RibavirinAlso: Rebetol, SCH 018908, MK-8908Ribavirin given in combination with peginterferon alpha according to local labeling guidelines | Drug | Peginterferon alpha and ribavirin |
Primary outcome
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)
Time frame: Up to 12 Weeks
An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.
Incidence of Thrombocytopenia
Time frame: Up to 12 Weeks
Thrombocytopenia is a low blood platelet count
Incidence of Treatment Discontinuations Due to Adverse Events
Time frame: Up to 12 Weeks
All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.
Incidence of Particular Adverse Events Resulting in Treatment Discontinuation
Time frame: Up to 12 Weeks
All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS). The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)
Incidence of Dose Modifications Due to Adverse Events
Time frame: Up to 12 Weeks
All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.
1 secondary outcome
Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- 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, 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 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 26 Nov 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?
Yes. Results are posted in the registry (first posted 20 Nov 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?
Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) (time frame: Up to 12 Weeks). The study lists 5 primary outcomes in all. 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 26 Nov 2014.