Hepatitis C, ChronicPhase 4NCT00375661
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
A Phase 4 study testing interferon-alfa-2b and ribavirin in people with Hepatitis C, Chronic, run by Kyoto University at 2 sites in Japan.
Trial summary
The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- interferon-alfa-2b and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2006to Mar 2013
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.
- Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy
Who cannot join
- No recurrence of hepatocellular carcinoma 3 months after the primary treatment
- Renal dysfunction
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Kyoto
Osaka Red Cross Hospital
Osaka
About this study
Official title: Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma
The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.
- Conditions
- Hepatitis C, Chronic
- Being tested
- interferon-alfa-2b and ribavirin
- Keywords
- hepatocellular carcinoma
- Medical subject headings
- Hepatitis C, Chronic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-alfa-2b and ribavirinDrug
Interferon, pnce per week plus daily ribavirin
| Study group | Role | What they receive |
|---|---|---|
| interferon | No intervention | Not described Receives: Drug: interferon-alfa-2b and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse effect of interferon
Measured: During the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2012
- Study completionMar 2013
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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroyuki Marusawa, Kyoto University
- Investigators
- Tsutomu Chiba, M.D.,Ph.D., Study chair, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375661
- Sponsor's protocol ID
- O2006-415
- Status last verified
- Sep 2015
- First submitted
- 12 Sep 2006
- Last updated
- 2 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00375661
- Acronym / sponsor ID
- O2006-415
- Conditions
- Hepatitis C, Chronic
- Keywords
- hepatocellular carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2006 (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 purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interferon | No intervention | Drug: interferon-alfa-2b and ribavirin |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.
- Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy
Key exclusion criteria (2 listed)
- No recurrence of hepatocellular carcinoma 3 months after the primary treatment
- Renal dysfunction
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 |
|---|---|---|
| interferon-alfa-2b and ribavirinInterferon, pnce per week plus daily ribavirin | Drug | interferon |
Primary outcome
Incidence of adverse effect of interferon
Time frame: During the treatment period
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 2 Sep 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.
Tsutomu Chiba, M.D.,Ph.D. study chair
Kyoto University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing interferon-alfa-2b and ribavirin in people with Hepatitis C, Chronic, run by Kyoto University at 2 sites in Japan.
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 2 inclusion and 2 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 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Incidence of adverse effect of interferon (time frame: During the treatment period). 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 2 Sep 2015.