Sustained Virologic ResponsePhase 4NCT01378104
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
A Phase 4 study testing peginterferon alfa 2a (pegasys) and peginterferon alfa-2a (pegasys) in people with Sustained Virologic Response and IL28B Polymorphism, run by The Catholic University of Korea at 14 sites in South Korea.
Trial summary
1. Randomized controlled multicenter study 2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1 3. IL28B polymorphism in Koreans with CHC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sustained Virologic Response, IL28B Polymorphism
- What is being tested?
- peginterferon alfa 2a (pegasys) and peginterferon alfa-2a (pegasys)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Oct 2008to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- chronic hepatitis C (anti HCV+, HCV RNA +)
- Genotype 1
- over 18 year-old
- Pregnancy test negative if women of childbearing age
Who cannot join
- pregnant women or breast feeding women
- systemic chemotherapy or steroid therapy before 6 months of trial
- Coinfection with HAV, HBV, and HIV
- Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
- Hepatocellular carcinoma
- Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
Show all 11Show fewer
- ANC less than 1500, platelet less than 90k
- Cr more than 1.5 of UNL
- Severe psychiatric problem
- Poorly controlled thyroid disease
- Severe retinopathy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Soonchunghyang University Hospital
Bucheon-si
Hallym University Chunchun Medical center
Chunchun
Keimyung University hospital
Daegu
Kyungpook National University Hospital
Daegu
Ghungnam National University hospital
Daejun
Konyang University hospital
Daejun
Incheon St. Mary's Hospital
Incheon
Inha University hospital
Incheon
Inje University, Ilsan Paik Hospital
Koyang-si
NHIC Ilsan hospital
Koyang-si
Inje University, Pusan Paik Hospital
Pusan
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Ulsan university
Ulsan
Yonsei University, Wonju Hospital
Wŏnju
About this study
Official title: The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
- Randomized controlled multicenter study
- The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
- IL28B polymorphism in Koreans with CHC
Read the detailed description
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
- Conditions
- Sustained Virologic Response, IL28B Polymorphism
- Being tested
- peginterferon alfa 2a (pegasys), peginterferon alfa-2a (pegasys)
- Keywords
- reducing dose of peginterferon, chronic hepatitis c, Koreans, IL28B polymorphism
- 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 (pegasys)Drug
Also called Roche
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
peginterferon alfa-2a (pegasys)Drug
Also called Roche
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
| Study group | Role | What they receive |
|---|---|---|
| 80% dosage group of peginterferon alfa 2a | Experimental | This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. Receives: Drug: peginterferon alfa 2a (pegasys) |
| 100% dosage group of peginterferon alfa 2a | Active comparator | These group patients would be treated with standard dose 180 ug/week for 48 weeks. Receives: Drug: peginterferon alfa-2a (pegasys) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
Measured: post treatment 24 weeks
Secondary outcomes (1)
IL28B Polymorphism Effect on SVR
We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.
Measured: post treatment 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sustained Virologic ResponseStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan University Hospital, National Health Insurance Service Ilsan Hospital, Inje University, Soonchunhyang University Hospital, Yonsei University, Chungnam National University, Keimyung University, Kyungpook National University Hospital, Konyang University Hospital, Inha University Hospital, Hallym University Medical Center
- Responsible party
- Principal investigator, Jung Hyun Kwon, The Catholic University of Korea
- Investigators
- Jung Hyun Kwon, MD, Assistant professor, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378104
- Sponsor's protocol ID
- PEGASYS100:80
- Status last verified
- Feb 2013
- First submitted
- 16 Jun 2011
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
- ClinicalTrials.gov ID
- NCT01378104
- Acronym / sponsor ID
- PEGASYS100:80
- Conditions
- Sustained Virologic Response, IL28B Polymorphism
- Keywords
- reducing dose of peginterferon, chronic hepatitis c, Koreans, IL28B polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Ulsan University Hospital, National Health Insurance Service Ilsan Hospital, Inje University, Soonchunhyang University Hospital, Yonsei University, Chungnam National University, Keimyung University, Kyungpook National University Hospital, Konyang University Hospital, Inha University Hospital, Hallym University Medical Center
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Randomized controlled multicenter study
- The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
- IL28B polymorphism in Koreans with CHC
Detailed description
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80% dosage group of peginterferon alfa 2a | Experimental | Drug: peginterferon alfa 2a (pegasys)This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment. |
| 100% dosage group of peginterferon alfa 2a | Active comparator | Drug: peginterferon alfa-2a (pegasys)These group patients would be treated with standard dose 180 ug/week for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic hepatitis C (anti HCV+, HCV RNA +)
- Genotype 1
- over 18 year-old
- Pregnancy test negative if women of childbearing age
Key exclusion criteria (11 listed)
- pregnant women or breast feeding women
- systemic chemotherapy or steroid therapy before 6 months of trial
- Coinfection with HAV, HBV, and HIV
- Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
- Hepatocellular carcinoma
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 (pegasys)Also: Rochedosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable | Drug | 80% dosage group of peginterferon alfa 2a |
| peginterferon alfa-2a (pegasys)Also: RocheThese patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose. | Drug | 100% dosage group of peginterferon alfa 2a |
Primary outcome
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
Time frame: post treatment 24 weeks
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
1 secondary outcome
IL28B Polymorphism Effect on SVR
Time frame: post treatment 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Predictors of HCC in Post-HCV Cirrhotic Patients After SVR
HCC - Hepatocellular Carcinoma
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Exploring the Knowledge, Attitudes, Behaviors and Perceived Barriers of Hepatologists Towards Non-invasive Hepatocellular Carcinoma Prediction Models in Hepatitis C Patients Who Achieved Sustained Virological Response Following Direct Acting Antivirals Therapy
Non-invasive Hepatocellular Carcinoma
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.
Jung Hyun Kwon, MD, Assistant professor principal investigator
The Catholic University of Korea
14 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 (pegasys) and peginterferon alfa-2a (pegasys) in people with Sustained Virologic Response and IL28B Polymorphism, run by The Catholic University of Korea at 14 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 4 inclusion and 11 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a (time frame: post treatment 24 weeks). 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 8 Mar 2013.