Hepatitis C VirusNCT00956982
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
A study testing Pegylated interferon alpha-2b plus ribavirin in people with Hepatitis C Virus, run by Kyushu University at 1 site in Japan.
Trial summary
The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- Pegylated interferon alpha-2b plus ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,251 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2004to Dec 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
- All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.
Who cannot join
- Clinical or biochemical evidence of hepatic decompensation.
- Advanced cirrhosis identified by large esophageal varices (F2 or F3).
- History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
- Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
- Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
- Excessive active alcohol consumption > 60 g/day or drug abuse.
- Severe psychiatric disease.
- Antiviral or corticosteroid therapy within 12 months prior to the enrollment.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of General Medicine, Kyushu University Hospital
Fukuoka, 812-8582
Mosaburo Kainuma, +81-92-642-5909, kainuma@genmedpr.med.kyushu-u.ac.jp
Jun Hayashi
About this study
Official title: Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C
The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).
- Conditions
- Hepatitis C Virus
- Being tested
- Pegylated interferon alpha-2b plus ribavirin
- Keywords
- Hepatitis C Virus Pegylated Interferon Ribavirin Older
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alpha-2b plus ribavirinDrug
All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively
What is being measured
The primary outcome is the main question the study is designed to answer.
antiviral effect by PEG-IFN alpha-2b plus RBV treatment
Measured: 24-weeks follow-up after the end of treatment
Secondary outcomes (1)
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
Measured: during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startDec 2004
- Primary completionJul 2008
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,251 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Investigators
- Jun Hayashi, Principal investigator, Department of General Medicine, Kyushu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956982
- Sponsor's protocol ID
- KULDS2009
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00956982
- Acronym / sponsor ID
- KULDS2009
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C Virus Pegylated Interferon Ribavirin Older
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,251 participants (estimated)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Aug 2009 (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 analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
- All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.
Key exclusion criteria (8 listed)
- Clinical or biochemical evidence of hepatic decompensation.
- Advanced cirrhosis identified by large esophageal varices (F2 or F3).
- History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
- Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
- Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
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 |
|---|---|---|
| Pegylated interferon alpha-2b plus ribavirinAll patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively | Drug | – |
Primary outcome
antiviral effect by PEG-IFN alpha-2b plus RBV treatment
Time frame: 24-weeks follow-up after the end of treatment
1 secondary outcome
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
Time frame: during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
Related trials for Hepatitis C Virus
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
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.
Jun Hayashi principal investigator
Department of General Medicine, Kyushu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegylated interferon alpha-2b plus ribavirin in people with Hepatitis C Virus, run by Kyushu University at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Hayashi (+81-92-642-5909, hayashij@genmedpr.med.kyushu-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antiviral effect by PEG-IFN alpha-2b plus RBV treatment (time frame: 24-weeks follow-up after the end of treatment). 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 11 Aug 2009.