Chronic Hepatitis CPhase 4NCT01056172
PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Pusan National University Yangsan Hospital at 8 sites in South Korea.
Trial summary
This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Jan 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years old
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum quantitative HCV-RNA
- HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Who cannot join
- Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Decompensated liver disease (Child-Pugh class B or C)
- Neoplastic disease within 5 years
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Women with ongoing pregnancy or breast feeding
Show all 16Show fewer
- Hgb < 11 g/dL in women or < 12 g/dL in men at screening
- Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
- Serum creatinine level > 1.5 times the upper limit of normal at screening
- Serum alpha-fetoprotein > 100 ng/mL
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- History of a severe seizure disorder or current anticonvulsant use
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites, 7 recruiting
- Recruiting
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, 420-767
Young Seok Kim, 82-10-6360-2635, liverkys@schbc.ac.kr
Young Seok Kim
- Recruiting
Pusan National University Hospital
Busan, 602-739
Jeong Heo, M.D, Ph.D, +82-51-240-7869, jheo@pusan.ac.kr
Jeong Heo, M.D, Ph.D
- Recruiting
Inje University Pusan Paik Hospital
Busan, 633-165
Youn Jae Lee, 08-10-7747-9281, yjyh0105@inje.ac.kr
Eun Uk Jung
- Recruiting
Inje University Haeundae Paik Hospital
Busan
Seung Ha Park, M.D., +82-10-4718-4545, obgyy@medimail.co.kr
Seung Ha Park, M.D.
- Active, not recruiting
Inje University Ilsan Paik Hospital
Goyang
- Recruiting
Incheon St. Mary's Hospital
Incheon
Jeong Won Jang, 82-11-204-9400, garden@catholic.ac.kr
Jeong Woon Jang
- Recruiting
Severance Hospital
Seoul, 120-752
Jun Yong Park, M.D, +82-10-8353-0670, drpjy@yuhs.ac
Jun Yong Park, M.D
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
Ki Tae Yoon, M.D, +82-55-360-2362, ktyoon@pusan.ac.kr
Ki Tae Yoon, M.D
About this study
Official title: A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response
This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
Read the detailed description
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa-2a and Ribavirin
- Keywords
- Chronic hepatitis C, Genotype 2, Rapid virologic response, Sustained virologic response, Peginterferon alfa-2a, 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.
Peginterferon alfa-2a and RibavirinDrug
- PegIFN alfa-2a (PEgasys) 180 ug/week
- Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
- Treatment duration: 16 weeks
Peginterferon alfa-2a and RibavirinDrug
- PegIFN alfa-2a (PEgasys) 180 ug/week
- Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day)
- Treatment duration: 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A. 24 weeks in RVR patients. | Active comparator | Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR. Receives: Drug: Peginterferon alfa-2a and Ribavirin |
| B. 16 weeks in RVR patients. | Experimental | Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR. Receives: Drug: Peginterferon alfa-2a and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR)
Measured: 24 weeks post-treatment (week 40 or week 48)
Secondary outcomes (3)
AEs
- 16 weeks treatment arm: 40 weeks
- 24 weeks treatment arm: 48 weeks
Measured: up to 24 weeks after last treatment visit
laboratory parameters
- 16 weeks treatment arm: 40 weeks
- 24 weeks treatment arm: 48 weeks
Measured: up to 24 weeks after last treatment visit
vital signs
- 16 weeks treatment arm: 40 weeks
- 24 weeks treatment arm: 48 weeks
Measured: up to 24 weeks after last treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012 (estimated)
- 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 Chronic Hepatitis CStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Pusan National University Hospital, Incheon St.Mary's Hospital, Soon Chun Hyang University, Inje University, Inje University Ilsan Paik Hospital, Inje University Haeundae Paik Hospital
- Responsible party
- Principal investigator, Ki Tae Yoon, Pusan National University Yangsan Hospital
- Investigators
- Ki Tae Yoon, M.D, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056172
- Sponsor's protocol ID
- PNUYH-CHC001
- Status last verified
- Apr 2012
- First submitted
- 25 Jan 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response
- ClinicalTrials.gov ID
- NCT01056172
- Acronym / sponsor ID
- PNUYH-CHC001
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Genotype 2, Rapid virologic response, Sustained virologic response, Peginterferon alfa-2a, Ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, Pusan National University Hospital, Incheon St.Mary's Hospital, Soon Chun Hyang University, Inje University, Inje University Ilsan Paik Hospital, Inje University Haeundae Paik Hospital
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 26 Jan 2010 (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 study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
Detailed description
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. 24 weeks in RVR patients. | Active comparator | Drug: Peginterferon alfa-2a and RibavirinPeginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR. |
| B. 16 weeks in RVR patients. | Experimental | Drug: Peginterferon alfa-2a and RibavirinPeginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age older than 18 years old
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum quantitative HCV-RNA
- HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Key exclusion criteria (16 listed)
- Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Decompensated liver disease (Child-Pugh class B or C)
- Neoplastic disease within 5 years
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
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-2a and Ribavirin1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) 3. Treatment duration: 16 weeks | Drug | B. 16 weeks in RVR patients. |
| Peginterferon alfa-2a and Ribavirin1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) 3. Treatment duration: 24 weeks | Drug | A. 24 weeks in RVR patients. |
Primary outcome
Sustained virologic response (SVR)
Time frame: 24 weeks post-treatment (week 40 or week 48)
3 secondary outcomes
AEs
Time frame: up to 24 weeks after last treatment visit
laboratory parameters
Time frame: up to 24 weeks after last treatment visit
vital signs
Time frame: up to 24 weeks after last treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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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.
Ki Tae Yoon, M.D principal investigator
Pusan National University Yangsan Hospital
8 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 Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by Pusan National University Yangsan Hospital at 8 sites in South Korea.
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 5 inclusion and 16 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Tae Yoon, M.D (+82-55-360-2362, ktyoon@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virologic response (SVR) (time frame: 24 weeks post-treatment (week 40 or week 48)). 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 20 Apr 2012.