Hepatitis C, ChronicPhase 3NCT00687219
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
A Phase 3 study testing Peginterferon alfa-2b and Ribavirin in people with Hepatitis C, Chronic and Liver Cirrhosis, run by Merck Sharp & Dohme LLC.
Trial summary
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. 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?
- Peginterferon alfa-2b and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Oct 2010
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 years.
- Positive quantitative serum HCV-RNA.
- Participants classified as A in Child-Pugh classification, and who do not have ascites or hepatic encephalopathy.
- Diagnosed with type C compensated liver cirrhosis based on liver biopsy performed within 3 years or latest celioscopy.
- Prolonged prothrombin time by <=3.0 sec.
- Participants and partners of participants willing to use adequate contraception during the course of the study.
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- Participants who can be hospitalized for at least 14 days since treatment initiation.
- Weight >40 kg and <=100 kg
- Hematology laboratory results of:
- hemoglobin >=12 g/dL
- neutrophil count >=1,500/mm^3
- platelet count >=70,000/ mm^3
- Blood chemistry results of:
- albumin and direct bilirubin within normal limits
- alpha fetoprotein (AFP) within reference range
- AFP-L3<=10%
- Protein induced by vitamin K (PIVKA)-II <=100 mAU/mL
Who cannot join
- Participants who did not previously respond virologically to combination therapy with interferon (including polyethylene glycol-modified interferon) and ribavirin
- Participants who had previously received treatment with interferon for whom at least 90 days have not elapsed since the end of previous treatment
- Participants who have received treatment within 14 days prior to registration with injectable preparations containing glycyrrhizin/cysteine/glycyron or shosaikoto
- Participants who have received administration of drugs having antiviral, anti-tumor, or immuno-modulating effect (including glucocorticoids and radiation therapy) within 90 days prior to registration (excluding local administration and topicals)
- Participants who have received other investigational drugs within 180 days prior to registration
- Hepatitis B surface (HBs) antigen positive
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- Antinuclear antibody >=320 times
- Serum creatinine exceeding the upper limit of reference range
- Participants with fasting blood glucose >=110 mg/dL (participants with fasting blood glucose >=110 mg/dL and <126 mg/dL can be registered if their hemoglobin A1C (HbA1c) is <6.5%) [fasting blood glucose should be measured when participants are not receiving treatment for diabetes mellitus]
- Participants with any of the following: diabetes mellitus that requires treatment; thyroid function disorder not controlled by treatment; liver disease such as autoimmune, alcoholic and drug-induced liver diseases; hemophilia; arrhythmia requiring treatment; co-existing hypertension not controlled by drug therapy (systolic blood pressure [BP] >=160mmHg or diastolic BP>=100mmHg); chronic pulmonary disease; hemoglobinopathies (thalassemia, sickle cell anemia); malignant tumors or who have a history of malignant tumor within the past 5 years; organ transplants (other than cornea and hair transplant)
- Participants with or who have a history of primary biliary cirrhosis, liver failure, hepatic carcinoma; decompensated liver cirrhosis with any the following diseases: ascites, jaundice, variceal hemorrhage, esophageal or gastric varices requiring treatment, hepatic encephalopathy, and idiopathic bacterial peritonitis; depression or schizophrenia requiring treatment, or suicidal attempt or suicidal ideation; epileptic seizures requiring treatment; angina, cardiac failure, myocardial infarction, or life-threatening arrhythmia; autoimmune disease (Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, scleroderma, etc.); hepatic carcinoma
- Participants with a history of hypersensitivity to interferon preparations, biological products such as vaccine, or nucleoside analogs, and those with specific reaction to pegylated interferon alfa-2b in the prick test conducted before the initiation of treatment
- Women who are pregnant or nursing as well as women for whom pregnancy cannot be ruled out by serum human chorionic gonadotropin (HCG) test conducted during the screening period. Male participants with partners who are pregnant.
About this study
Official title: Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.
- Conditions
- Hepatitis C, Chronic, Liver Cirrhosis
- Being tested
- Peginterferon alfa-2b, Ribavirin
- Keywords
- hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2bBiological
Also called SCH 054031
Administered at 1.0 µg/kg/week SC for 48 weeks
RibavirinDrug
Also called SCH 018908
Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL; treatment duration is 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2b + Ribavirin | Experimental | Not described Receives: Biological: Peginterferon 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 Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Measured: Measured at 24 weeks after 48 weeks treatment (72 weeks)
Secondary outcomes (2)
Number of Participants With Undetectable HCV-RNA at Week 24
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Measured: Week 24
Number of Participants With Undetectable HCV-RNA at End of Treatment
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionOct 2010
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT00687219
- Sponsor's protocol ID
- P05116
- Other IDs
- JPC-06-320-35
- Status last verified
- Mar 2017
- First submitted
- 27 May 2008
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Compensated Liver Cirrhosis With SCH 54031 + Ribavirin
- ClinicalTrials.gov ID
- NCT00687219
- Acronym / sponsor ID
- P05116
- Conditions
- Hepatitis C, Chronic, Liver Cirrhosis
- Keywords
- hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 2 Dec 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 is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2b + Ribavirin | Experimental | Biological: Peginterferon alfa-2b, Drug: Ribavirin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adults aged 20-70 years.
- Positive quantitative serum HCV-RNA.
- Participants classified as A in Child-Pugh classification, and who do not have ascites or hepatic encephalopathy.
- Diagnosed with type C compensated liver cirrhosis based on liver biopsy performed within 3 years or latest celioscopy.
- Prolonged prothrombin time by <=3.0 sec.
Key exclusion criteria (13 listed)
- Participants who did not previously respond virologically to combination therapy with interferon (including polyethylene glycol-modified interferon) and ribavirin
- Participants who had previously received treatment with interferon for whom at least 90 days have not elapsed since the end of previous treatment
- Participants who have received treatment within 14 days prior to registration with injectable preparations containing glycyrrhizin/cysteine/glycyron or shosaikoto
- Participants who have received administration of drugs having antiviral, anti-tumor, or immuno-modulating effect (including glucocorticoids and radiation therapy) within 90 days prior to registration (excluding local administration and topicals)
- Participants who have received other investigational drugs 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 |
|---|---|---|
| Peginterferon alfa-2bAlso: SCH 054031Administered at 1.0 µg/kg/week SC for 48 weeks | Biological | Peginterferon alfa-2b + Ribavirin |
| RibavirinAlso: SCH 018908Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL; treatment duration is 48 weeks | Drug | Peginterferon alfa-2b + Ribavirin |
Primary outcome
Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
Time frame: Measured at 24 weeks after 48 weeks treatment (72 weeks)
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
2 secondary outcomes
Number of Participants With Undetectable HCV-RNA at Week 24
Time frame: Week 24
Number of Participants With Undetectable HCV-RNA at End of Treatment
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 Peginterferon alfa-2b and Ribavirin 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 17 inclusion and 13 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 7 Apr 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?
Yes. Results are posted in the registry (first posted 2 Dec 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 Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response) (time frame: Measured at 24 weeks after 48 weeks treatment (72 weeks)). 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 7 Apr 2017.