Hepatitis C, ChronicNCT00216775
Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C
An observational study of Hepatitis C, Chronic, run by Kyoto University at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- interferon-alfa-2b and ribavirin
- How many people
- 50 participants
- Where
- 4 sitesJapan
- Study dates
- Dec 2004to May 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic hepatitis C
Who may be able to join
- Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses
Who cannot join
- Hemoglobin levels<8.5g/dL,
- Platelet counts<50,000/mm3,
- Total polymorphonuclear counts<1000/mm3
- Pregnancy,
- Renal dysfunction,
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Kyoto, 606-8507
Kitano Hospital
Osaka
Osaka Red Cross Hospital
Osaka
Wakayama Red Cross Hospital
Wakayama
About this study
The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.
- Conditions
- Hepatitis C, Chronic
- Being tested
- interferon-alfa-2b and ribavirin
- 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.
interferon-alfa-2b and ribavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of sustained viral response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionMay 2008
- Study completionMay 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT00216775
- Sponsor's protocol ID
- H16-697
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2005
- 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
- Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00216775
- Acronym / sponsor ID
- H16-697
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Sep 2005 (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 evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic hepatitis C
Key inclusion criteria (1 listed)
- Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses
Key exclusion criteria (5 listed)
- Hemoglobin levels<8.5g/dL,
- Platelet counts<50,000/mm3,
- Total polymorphonuclear counts<1000/mm3
- Pregnancy,
- 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 ribavirin | Drug | – |
Primary outcome
rate of sustained viral response
Time frame: 6 months
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Kyoto University at 4 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 1 inclusion and 5 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 4 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.
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?
rate of sustained viral response (time frame: 6 months). 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.