Hepatitis C, ChronicPhase 3NCT00811967
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
A Phase 3 study testing PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908) in people with Hepatitis C, Chronic and Liver Cirrhosis, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic, Liver Cirrhosis
- What is being tested?
- PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to May 2006
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with compensated hepatic cirrhosis secondary to chronic hepatitis C who would meet all the inclusion criteria below and would not interfere with any of the exclusion criteria below.
- Patients (regardless of gender) who can take contraceptive measures from date of informed consent to the end of follow-up
- Patients who meet all the criteria below in the test/observation/ investigation in 30 days before the beginning of treatment.
- Patients with quantitative HCV-RNA (+)
- ALT > 40 IU/L
- Patients who are classified as Child-Pugh Classification A, and who do not have ascites or hepatic encephalopathy
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- Prothrombin Time <=3.0 seconds prolonged, total bilirubin <= 1.5 mg/dL or direct bilirubin <= 0.7 mg/dL, Albumin >= 3.0 g/dL
- AFP within normal limits, AFP-L3 <= 10%，PIVKA-II <= 100 mAU/mL
- Serum creatinine <= upper limit of normal, creatinine clearance >= 51 mL/minute
- Patients with fasting blood glucose < 110 mg/dL.
- Thyroid-stimulating hormone within normal limits
- Hemoglobin level >= 12 g/dL，leukocyte count >= 3,000/mm3，neutrophil count >= 1,500 /mm3，platelet count >= 80,000/mm3
- Patients who weighs more than 40 kg and not more than 100 kg within 60 days prior to registration
- Patients who were diagnosed with liver cirrhosis (fibrosis score: F4) based on the liver biopsy performed within a year prior to registration and is able to provide with liver tissue sample.
- Patients who between the ages of 20 and 70 years at time of informed consent who can give written informed consent
- Patients who can be hospitalized at least for 14 days from the initiation of treatment.
Who cannot join
- Patients who have been administered pegylated interferon or ribavirin in the past.
- Patients who had previously received treatment with IFN for whom at least 90 days have not elapsed since the end of previous treatment by the time of registration in the study
- Patients who have received treatment within 14 days prior to registration with the injectable preparations containing glycyrrhizin/cysteine/glycyron (Stronger Neo-Minophagen C, etc.), or shosaikoto
- Patients who have had antiviral drug or antitumor drug, or immune regulation therapy (including steroid administration, radiation therapy) within 90 days prior to registration. [except for topical application and external drug]
- Patients who have been administered any study drug within 180 days prior to registration.
- Patients who meet the following criteria in the screening test
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- HBs antigen positive
- antinuclear antibody >= 320 times
- Patients with or who have a history of primary biliary cirrhosis, hepatic failure, hepatocellular carcinoma.
- Patients with other etiologies of liver disease such as autoimmune, alcoholic and drug-induced liver diseases
- Patients with or who have a history of decompensated cirrhosis with following disorder. Ascites, jaundice, bleeding varices, esophageal and/or gastric varices which needs treatment, hepatic encephalopathy, and spontaneous bacterial peritonitis.
- Patients with hemophilia
- Patients with or who have a history of neuropsychiatry disorder such as depression.
- Patients with or who have a history of epileptic seizures requiring treatment
- Patients with or who have a history of angina pectoris, heart failure, myocardial infarction, uncontrollable hypertension (diastolic blood pressure: equal to or more than 110mmHg) or arrhythmia which needs treatment.
- Patients with chronic pulmonary disease
- Patients with or who have a history of autoimmune disease (Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc).
- Patients with Hemoglobinopathies (thalassaemia, sickle cell anemia)
- Patients with malignant tumors
- Patients with organ transplants (other than cornea and hair transplant).
- Patients with a history of hypersensitivity to interferon preparations, biological products such as vaccine, or nucleoside analogs
- Female patients who are pregnant or nursing (male patients with partner who are pregnant), and for whom pregnancy cannot be ruled out by serum HCG test conducted during the screening period
- Patients with specific reaction to PEG-IFNα-2b in prick test conducted before the initiation of treatment（Only PEG/R group）
- Other patients judged by the investigator (sub-investigator) to be inappropriate for inclusion in this study
About this study
Official title: Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and enter Follow-up.
- Conditions
- Hepatitis C, Chronic, Liver Cirrhosis
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis
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 a dose of 1.5 ug/kg QW SC for up to 48 weeks
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered at a dose of 600, 800, or 1000 mg/day, orally, for up to 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up
Measured: Measured at 24 weeks post-treatment
Secondary outcomes (1)
Rate of subject with undetectable HCV-RNA at the end of treatment (or at discontinuation of treatment)
Measured: Measured at the end of treatment (or at discontinuation of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startFeb 2003
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00811967
- Sponsor's protocol ID
- P03811
- Other IDs
- JPC-02-320-34
- Status last verified
- Mar 2017
- First submitted
- 18 Dec 2008
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT00811967
- Acronym / sponsor ID
- P03811
- Conditions
- Hepatitis C, Chronic, Liver Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Dec 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.
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and enter Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908) |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with compensated hepatic cirrhosis secondary to chronic hepatitis C who would meet all the inclusion criteria below and would not interfere with any of the exclusion criteria below.
- Patients (regardless of gender) who can take contraceptive measures from date of informed consent to the end of follow-up
- Patients who meet all the criteria below in the test/observation/ investigation in 30 days before the beginning of treatment.
- Patients who weighs more than 40 kg and not more than 100 kg within 60 days prior to registration
- Patients who were diagnosed with liver cirrhosis (fibrosis score: F4) based on the liver biopsy performed within a year prior to registration and is able to provide with liver tissue sample.
Key exclusion criteria (24 listed)
- Patients who have been administered pegylated interferon or ribavirin in the past.
- Patients who had previously received treatment with IFN for whom at least 90 days have not elapsed since the end of previous treatment by the time of registration in the study
- Patients who have received treatment within 14 days prior to registration with the injectable preparations containing glycyrrhizin/cysteine/glycyron (Stronger Neo-Minophagen C, etc.), or shosaikoto
- Patients who have had antiviral drug or antitumor drug, or immune regulation therapy (including steroid administration, radiation therapy) within 90 days prior to registration. [except for topical application and external drug]
- Patients who have been administered any study drug within 180 days prior to registration.
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 a dose of 1.5 ug/kg QW SC for up to 48 weeks | Biological | Treatment Arm |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered at a dose of 600, 800, or 1000 mg/day, orally, for up to 48 weeks. | Drug | Treatment Arm |
Primary outcome
Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up
Time frame: Measured at 24 weeks post-treatment
1 secondary outcome
Rate of subject with undetectable HCV-RNA at the end of treatment (or at discontinuation of treatment)
Time frame: Measured at the end of treatment (or at discontinuation of treatment)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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?
A Phase 3 study testing PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908) in people with Hepatitis C, Chronic and Liver Cirrhosis, 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 16 inclusion and 24 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 13 Mar 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up (time frame: Measured at 24 weeks post-treatment). 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 13 Mar 2017.