Hepatitis C, ChronicPhase 2NCT00787371
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
A Phase 2 study testing PegIntron (peginterferon alfa-2b) in people with Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron (peginterferon alfa-2b)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jul 2006
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:
- At least 20 years of age and willing to sign an informed consent
- Patients who can practice contraception
- Patients who are classified either as relapsers or non-responders.
- Weight between 45 and 100 kg
- Patients willing to be hospitalized for 3 days after the start of treatment
Show all 10Show fewer
- Patients with positive HCV-RNA
- Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
- Neutrophil count: equal to or more than 1,200 /mm^3
- Platelet count：equal to or more than 100,000/mm^3
Who cannot join
- Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
About this study
Official title: Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (peginterferon alfa-2b)
- Keywords
- alanine transaminase
- 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)Biological
Also called PegIntron, peginterferon alfa-2b, SCH 54031
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
PegIntron (peginterferon alfa-2b)Biological
Also called PegIntron, peginterferon alfa-2b, SCH 54031
PegIntron 0.5 mcg/kg SC QW for 12 weeks
PegIntron (peginterferon alfa-2b)Biological
Also called PegIntron, peginterferon alfa-2b, SCH 54031
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.25 Dose Group | Experimental | PegIntron 0.25 mcg/kg SC QW for 12 weeks Receives: Biological: PegIntron (peginterferon alfa-2b) |
| 0.5 Dose Group | Experimental | PegIntron 0.5 mcg/kg SC QW for 12 weeks Receives: Biological: PegIntron (peginterferon alfa-2b) |
| 1.0 Dose Group | Experimental | PegIntron 1.0 mcg/kg SC QW for 12 weeks Receives: Biological: PegIntron (peginterferon alfa-2b) |
| No-treatment Control | No intervention | No treatment (no placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieve normalization of ALT in each treatment group
Measured: Measured at the end of 12 weeks of treatment or at discontinuation.
Secondary outcomes (1)
Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)
Measured: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startJun 2005
- Primary completionJul 2006
- Study completionJul 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT00787371
- Sponsor's protocol ID
- P04508
- Other IDs
- JPC-04-356-20
- Status last verified
- Mar 2017
- First submitted
- 6 Nov 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
- Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00787371
- Acronym / sponsor ID
- P04508
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Keywords
- alanine transaminase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 7 Nov 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.
In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.25 Dose Group | Experimental | Biological: PegIntron (peginterferon alfa-2b)PegIntron 0.25 mcg/kg SC QW for 12 weeks |
| 0.5 Dose Group | Experimental | Biological: PegIntron (peginterferon alfa-2b)PegIntron 0.5 mcg/kg SC QW for 12 weeks |
| 1.0 Dose Group | Experimental | Biological: PegIntron (peginterferon alfa-2b)PegIntron 1.0 mcg/kg SC QW for 12 weeks |
| No-treatment Control | No intervention | –No treatment (no placebo) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 20 years of age and willing to sign an informed consent
- Patients who can practice contraception
- Patients who are classified either as relapsers or non-responders.
- Weight between 45 and 100 kg
- Patients willing to be hospitalized for 3 days after the start of treatment
Key exclusion criteria (1 listed)
- Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.
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)Also: PegIntron, peginterferon alfa-2b, SCH 54031PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks | Biological | 0.25 Dose Group |
| PegIntron (peginterferon alfa-2b)Also: PegIntron, peginterferon alfa-2b, SCH 54031PegIntron 0.5 mcg/kg SC QW for 12 weeks | Biological | 0.5 Dose Group |
| PegIntron (peginterferon alfa-2b)Also: PegIntron, peginterferon alfa-2b, SCH 54031PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks | Biological | 1.0 Dose Group |
Primary outcome
Percentage of patients who achieve normalization of ALT in each treatment group
Time frame: Measured at the end of 12 weeks of treatment or at discontinuation.
1 secondary outcome
Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)
Time frame: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up
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 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 2 study testing PegIntron (peginterferon alfa-2b) in people with 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 1 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Percentage of patients who achieve normalization of ALT in each treatment group (time frame: Measured at the end of 12 weeks of treatment or at discontinuation.). 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.