Chronic Hepatitis CPhase 4NCT01596517
Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
A Phase 4 study testing Peginterferon alfa-2a plus ribavirin for HCV genotype 1 and Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 in people with Chronic Hepatitis C, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa-2a plus ribavirin for HCV genotype 1 and Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2003to May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 18-70 years
- serum anti-HCV antibody (+)
- HCV RNA detectable by PCR
- compensated liver disease (Child-Pugh class A)
Who cannot join
- HCV genotype other than 1, 2, or 3
- acute hepatitis C
- decompensated cirrhosis or hepatocellular carcinoma
- other liver disease such as hepatitis A or B, or autoimmune hepatitis
- HIV Ab(+)
- severe depression or other psychiatric disease
- previous organ transplantation
- absolute neutrophil count (ANC) < 1,000 cells/mm3 or platelet count < 75,000 cells/mm3, or hemoglobin (Hb) < 13 g/dL for men, <12 g/dL for women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C
The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.
Read the detailed description
A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa-2a plus ribavirin for HCV genotype 1, Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
- 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 plus ribavirin for HCV genotype 1Drug
Also called Pegasys, Copegus
Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.
Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3Drug
Also called Pegasys, Copegus
Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Korean CHC | Experimental | Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008. Receives: Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1; Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving sustained virological response (SVR)
SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment
Measured: at 24 weeks after cessation of treatment
Secondary outcomes (3)
The proportion of patients achieving early virological response (EVR)
EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment
Measured: at 12 weeks of treatment
the proportion of patients achieving complete EVR (cEVR)
cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
Measured: at 12 weeks of treatment
The proportion of patients achieving end-of-treatment response (ETR)
ETR is defined as HCV RNA undetectable at the end of treatment.
Measured: at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJun 2003
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital
- Responsible party
- Principal investigator, Young-Suk Lim, Asan Medical Center
- Investigators
- Young-Suk Lim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596517
- Sponsor's protocol ID
- AMC2003-0059
- Status last verified
- May 2012
- First submitted
- 7 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heo NY, Lim YS, Lee HC, Lee YS, Kim KM, Byun KS, Han KH, Lee KS, Paik SW, Yoon SK, Suh DJ. High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice. Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25.
PubMed 23593611
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01596517
- Acronym / sponsor ID
- AMC2003-0059
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital
- Study start
- Jun 2003
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 May 2012 (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 investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.
Detailed description
A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean CHC | Experimental | Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1, Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults aged 18-70 years
- serum anti-HCV antibody (+)
- HCV RNA detectable by PCR
- compensated liver disease (Child-Pugh class A)
Key exclusion criteria (8 listed)
- HCV genotype other than 1, 2, or 3
- acute hepatitis C
- decompensated cirrhosis or hepatocellular carcinoma
- other liver disease such as hepatitis A or B, or autoimmune hepatitis
- HIV Ab(+)
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 plus ribavirin for HCV genotype 1Also: Pegasys, CopegusPatients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks. | Drug | Korean CHC |
| Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3Also: Pegasys, CopegusPatients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks. | Drug | Korean CHC |
Primary outcome
The proportion of patients achieving sustained virological response (SVR)
Time frame: at 24 weeks after cessation of treatment
SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment
3 secondary outcomes
The proportion of patients achieving early virological response (EVR)
Time frame: at 12 weeks of treatment
the proportion of patients achieving complete EVR (cEVR)
Time frame: at 12 weeks of treatment
The proportion of patients achieving end-of-treatment response (ETR)
Time frame: at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3
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 15 May 2012.
- Derived from this study: PubMed 23593611Heo NY, Lim YS, Lee HC, Lee YS, Kim KM, Byun KS, Han KH, Lee KS, Paik SW, Yoon SK, Suh DJ. High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice. Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25.
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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.
Young-Suk Lim, M.D., Ph.D. principal investigator
Asan Medical Center
1 site 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 plus ribavirin for HCV genotype 1 and Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 in people with Chronic Hepatitis C, run by Asan Medical Center at 1 site 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 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: finished, as of the sponsor's last update on 15 May 2012. 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 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?
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?
The proportion of patients achieving sustained virological response (SVR) (time frame: at 24 weeks after cessation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596517, which also lists 1 linked publication.
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 15 May 2012.