Hepatitis C, ChronicNCT00724295
Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- peginterferon alfa-2b and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,077 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in the clinical practice at approximately 100 to 200 institutions in Japan.
Who may be able to join
- Patients with chronic hepatitis C.
- Patients are serogroup 1(genotype I (1a) or II (1b)).
- The HCV-RNA level in the blood is more than 10^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method
Who cannot join
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- Patients with a history of hypersensitivity to biological products, such as vaccines
- Patients being treated with Shosaikoto
- Patients with autoimmune hepatitis
- Pregnant women, women who may be pregnant, and nursing mothers
- Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
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- Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
- Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
- Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
- Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
- Patients with serious hepatic dysfunction
- Patients with autoimmune hepatitis
About this study
Official title: PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C-
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- peginterferon alfa-2b, ribavirin
- 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.
peginterferon alfa-2bDrug
Also called PegIntron, SCH 54031
PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.
ribavirinDrug
Also called Rebetol, SCH 18908
Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Overall study population Receives: Drug: peginterferon alfa-2b; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of adverse events and adverse drug reactions.
Measured: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.
Measured: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Sustained virologic response rate and improvement of ALT (alanine transaminase).
Measured: Assessed at the end-of-treatment and at 24 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionDec 2008
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,077 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
- NCT00724295
- Sponsor's protocol ID
- P04505
- Status last verified
- Feb 2015
- First submitted
- 25 Jul 2008
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEG Intron/REBETOL Combination Therapy Special Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C-
- ClinicalTrials.gov ID
- NCT00724295
- Acronym / sponsor ID
- P04505
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jul 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.
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: peginterferon alfa-2b, Drug: ribavirinOverall study population |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in the clinical practice at approximately 100 to 200 institutions in Japan.
Key inclusion criteria (3 listed)
- Patients with chronic hepatitis C.
- Patients are serogroup 1(genotype I (1a) or II (1b)).
- The HCV-RNA level in the blood is more than 10^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method
Key exclusion criteria (12 listed)
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- Patients with a history of hypersensitivity to biological products, such as vaccines
- Patients being treated with Shosaikoto
- Patients with autoimmune hepatitis
- Pregnant women, women who may be pregnant, and nursing mothers
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: PegIntron, SCH 54031PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks. | Drug | Arm 1 |
| ribavirinAlso: Rebetol, SCH 18908Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks. | Drug | Arm 1 |
Primary outcome
Overall incidence of adverse events and adverse drug reactions.
Time frame: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.
Time frame: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.
Sustained virologic response rate and improvement of ALT (alanine transaminase).
Time frame: Assessed at the end-of-treatment and at 24 weeks post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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 3 inclusion and 12 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 4 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall incidence of adverse events and adverse drug reactions. (time frame: From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.). The study lists 3 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 4 Feb 2015.