Hepatitis C, ChronicNCT00727311
Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. 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) injector and Rebetol (ribavirin; SCH 18908)
- How many people
- 2,302 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Jun 2009
- 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: Participants with chronic hepatitis C, who are either treatment-naïve or previous relapsers after interferon monotherapy, from 500 sites in Germany
Who may be able to join
- Participants with chronic hepatitis C
- At least 18 years old
- Treatment-naïve or relapse to interferon monotherapy
- Platelets >= 100,000/mm^3
- Neutrophil counts >= 1,500/ mm^3
- Thyroid Stimulating Hormone (TSH) must be within normal limits
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- Hemoglobin >= 12 gr/dl (females); >= 13 gr/dl (males)
- Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months
- Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment
- Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment
Who cannot join
- Contraindications as per the SPC and approved European labeling
- Hypersensitivity to the active substance or to any inteferons or to any of the excipients
- Pregnant woman
- Woman who are breast-feeding
- Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
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- Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance < 50 mL/min
- Autoimmune hepatitis or history of autoimmune disease
- Severe hepatic dysfunction or decompensated cirrhosis of the liver
- Pre-existing thyroid disease unless it can be controlled with conventional therapy
- Epilepsy and/or compromised central nervous system function
About this study
Official title: Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)
The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031) injector, 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) injectorBiological
Also called SCH 54031
PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling
| Study group | Role | What they receive |
|---|---|---|
| PegIntron + Rebetol | Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector; Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
HCV-RNA level was measured by polymerase chain reaction (PCR).
Measured: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
Number of Participants With Early Virologic Response (EVR)
EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA
negativity from baseline to Week 12
Measured: Treatment Week 12
Number of Participants With Sustained Virologic Response (SVR)
SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
Measured: 24 weeks post-treatment (Week 48 or 72, depending on genotype)
Number of HCV-RNA Negative Participants at Follow-up
HCV-RNA was measured by PCR.
Measured: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2005
- Primary completionJun 2009
- Study completionJun 2009
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,302 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
- NCT00727311
- Sponsor's protocol ID
- P04538
- Status last verified
- Oct 2015
- First submitted
- 30 Jul 2008
- Last updated
- 9 Oct 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 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (Post Marketing Surveillance Study)
- ClinicalTrials.gov ID
- NCT00727311
- Acronym / sponsor ID
- P04538
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,302 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 10 Jan 2011
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 the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegIntron + Rebetol | – | Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector, Drug: Rebetol (ribavirin; SCH 18908)Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic hepatitis C, who are either treatment-naïve or previous relapsers after interferon monotherapy, from 500 sites in Germany
Key inclusion criteria (10 listed)
- Participants with chronic hepatitis C
- At least 18 years old
- Treatment-naïve or relapse to interferon monotherapy
- Platelets >= 100,000/mm^3
- Neutrophil counts >= 1,500/ mm^3
Key exclusion criteria (11 listed)
- Contraindications as per the SPC and approved European labeling
- Hypersensitivity to the active substance or to any inteferons or to any of the excipients
- Pregnant woman
- Woman who are breast-feeding
- Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
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) injectorAlso: SCH 54031PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling | Biological | PegIntron + Rebetol |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling | Drug | PegIntron + Rebetol |
Primary outcome
Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)
Time frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6
HCV-RNA level was measured by polymerase chain reaction (PCR).
Number of Participants With Early Virologic Response (EVR)
Time frame: Treatment Week 12
EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12
Number of Participants With Sustained Virologic Response (SVR)
Time frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype)
SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
Number of HCV-RNA Negative Participants at Follow-up
Time frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype)
HCV-RNA was measured by PCR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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, 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 10 inclusion and 11 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 9 Oct 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 10 Jan 2011). 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 Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) (time frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6). The study lists 4 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 9 Oct 2015.