Hepatitis C, ChronicPhase 4NCT00255008
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)
A Phase 4 study testing peginterferon alfa-2b and ribavirin in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. 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 alfa-2b and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2007
- Phase
- Phase 4
- 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
Who may be able to join
- Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
- Able to give written informed consent and adhere to study visit schedule.
- South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
- Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
- Hemoglobin >=120 g/L (females), >=130 g/L (males).
- Platelet count >=100 x 10^9/L.
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- Neutrophil count >=1.5 x 10^9/L.
- Negative pregnancy test for females.
- Thyroid stimulating hormone (TSH) within normal limits.
Who cannot join
- Participation in any other investigational drug program within 30 days of the Screening Visit.
- Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
- Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
- Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
- Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
- Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
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- Inability to comply with study requirements for other reasons.
- Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
- Present or prior history of severe psychiatric disease requiring hospitalization or medication.
- History of severe seizure disorder.
- History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis).
- Poorly controlled thyroid disease.
- Creatinine clearance <50 mL/min.
- Severe cardiovascular disease.
- Hepatocellular cancer.
- Clinically significant ophthalmologic disorders.
- Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia).
- Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.
About this study
Official title: SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2b, ribavirin
- Keywords
- chronic hepatitis C, pegylated interferon alfa-2b, ribavirin, Asia
- 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 alfa-2bBiological
Also called SCH 54031, PegIntron REDIPEN
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
ribavirinDrug
Also called SCH 18908, REBETOL
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
peginterferon alfa-2bBiological
Also called SCH 54031, PegIntron REDIPEN
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
ribavirinDrug
Also called SCH 18908, REBETOL
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Genotype 1 SEA PEG-IFN/RIB 48 w | Active comparator | Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy Receives: Biological: peginterferon alfa-2b; Drug: ribavirin |
| Genotype 1 Caucasian PEG-IFN/RIB 48 w | Active comparator | Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy Receives: Biological: peginterferon alfa-2b; Drug: ribavirin |
| Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w | Experimental | Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy Receives: Biological: peginterferon alfa-2b; Drug: ribavirin |
| Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w | Active comparator | Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy 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 Subjects Who Achieved a Sustained Virologic Response (SVR)
SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.
Measured: 24 weeks after completion of either up to 24 or 48 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Slow enrollment
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 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
- NCT00255008
- Sponsor's protocol ID
- P04212
- Status last verified
- Mar 2017
- First submitted
- 15 Nov 2005
- Last updated
- 6 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 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.
- ClinicalTrials.gov ID
- NCT00255008
- Acronym / sponsor ID
- P04212
- Conditions
- Hepatitis C, Chronic
- Keywords
- chronic hepatitis C, pegylated interferon alfa-2b, ribavirin, Asia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Nov 2005 (estimated)
- Results
- Posted 6 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Genotype 1 SEA PEG-IFN/RIB 48 w | Active comparator | Biological: peginterferon alfa-2b, Drug: ribavirinGenotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy |
| Genotype 1 Caucasian PEG-IFN/RIB 48 w | Active comparator | Biological: peginterferon alfa-2b, Drug: ribavirinGenotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy |
| Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w | Experimental | Biological: peginterferon alfa-2b, Drug: ribavirinGenotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy |
| Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w | Active comparator | Biological: peginterferon alfa-2b, Drug: ribavirinGenotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
- Able to give written informed consent and adhere to study visit schedule.
- South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
- Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
- Hemoglobin >=120 g/L (females), >=130 g/L (males).
Key exclusion criteria (18 listed)
- Participation in any other investigational drug program within 30 days of the Screening Visit.
- Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
- Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
- Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
- Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
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 54031, PegIntron REDIPENPowder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks | Biological | Genotype 1 Caucasian PEG-IFN/RIB 48 w, Genotype 1 SEA PEG-IFN/RIB 48 w, Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w |
| ribavirinAlso: SCH 18908, REBETOL200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks | Drug | Genotype 1 Caucasian PEG-IFN/RIB 48 w, Genotype 1 SEA PEG-IFN/RIB 48 w, Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w |
| peginterferon alfa-2bAlso: SCH 54031, PegIntron REDIPENPowder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks | Biological | Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w |
| ribavirinAlso: SCH 18908, REBETOL200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks | Drug | Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w |
Primary outcome
Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
Time frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy
SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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 4 study testing peginterferon alfa-2b and ribavirin in people with 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 9 inclusion and 18 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 6 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Jan 2010). 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 Subjects Who Achieved a Sustained Virologic Response (SVR) (time frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy). 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 6 Apr 2017.