Chronic Hepatitis CPhase 4NCT00629967
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-1 Patients
A Phase 4 study testing pegylated interferon alpha 2a and ribavirin and Pegylated interferon alfa-2a and ribavirin in people with Chronic Hepatitis C and Genotype, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study are: 1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve a sustained virological response (SVR) rate comparable to that observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype 1 (HCV-1) patients achieving a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C, Genotype
- What is being tested?
- pegylated interferon alpha 2a and ribavirin and Pegylated interferon alfa-2a and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to May 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, 18-65 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA and HCV viral genotype 1
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
- Elevated serum alanine transaminase (ALT) levels for at least two measurements within 6 months preceding the trial entry.
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- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Neutrophil count >1500/mm3, platelet count >9×104/mm3, hemoglobin level >12 g/dL for men and >11 g/dL for women, serum creatinine level <1.5 mg/dL
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, 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)
- Signs or symptoms of hepatocellular carcinoma
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- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3, Hgb <11 g/dL in women or <12 g/dL in men at screening
- Any patient with major thalassemia
- Serum creatinine level >1.5 times the upper limit of normal at screening
- 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 a severe seizure disorder or current anticonvulsant use
- 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 of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
- Patients with HCV genotype other than 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Labeled, Active-Controlled Trial of 24-Week Versus 48-Week Courses of Peg-Interferon Alpha Plus Ribavirin for Genotype-1 Infected Chronic Hepatitis C Patients
The purposes of this study are:
- To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve a sustained virological response (SVR) rate comparable to that observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype 1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week 4) at 4 weeks.
- To investigate the role of on-treatment virological responses among patients with 24 or 48 weeks treatment.
Read the detailed description
Peginterferon and ribavirin combination treatment has been recommended for all patients infected with HCV, but the treatment duration varies depending on the HCV genotype. Recommended treatment for patients with HCV-1 infection is pegylated interferon plus ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR. Previous studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter duration of treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as effective as a 24-week treatment regimen. These findings have questioned whether shorter treatment duration can yield high SVR rates for HCV-1 pts with an RVR.
The primary aim of the present study is to evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.
The secondary aim is to investigate the role of on-treatment virologic responses among patients with 24 or 48 weeks treatment.
- Conditions
- Chronic Hepatitis C, Genotype
- Being tested
- pegylated interferon alpha 2a and ribavirin, Pegylated interferon alfa-2a and ribavirin
- Keywords
- chronic hepatitis C, genotype 1, rapid virological response, sustained virological response, peginterferon, ribavirin, treatment duration
- 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.
pegylated interferon alpha 2a and ribavirinDrug
Also called PEGASYS®
pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks
Pegylated interferon alfa-2a and ribavirinDrug
Also called PEGASYS®
Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Eligible patients will be randomized into two groups with a ratio of 1:1 (Arm A \& B) Receives: Drug: pegylated interferon alpha 2a and ribavirin |
| B | Active comparator | Eligible patients will be randomized into two groups with a ratio of 1:1 (Arm A \& B) Receives: Drug: Pegylated interferon alfa-2a and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Measured: 2 years
Secondary outcomes (3)
Safety - adverse event rate and profile
Measured: 2 years
Early virological response (EVR), by PCR-negative or 2 logs decline from baseline at week 12
Measured: 2 years
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startApr 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Lung Yu, MD, PhD, Principal investigator, Kaohsiung Medical UniversityChia-Yen Dai, MD, Ms, Principal investigator, Kaohsiung Municipal Hsiao-Kang HospitalChang-Fu Chiu, MD, Principal investigator, Paochien HospitalJee-Fu Huang, MD, Principal investigator, Foo Yin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629967
- Sponsor's protocol ID
- KMUH-IRB-94045
- Status last verified
- Jan 2008
- First submitted
- 26 Feb 2008
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
PubMed 15558712Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
PubMed 15057920Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.
PubMed 14996676Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.
PubMed 12324553Yu ML, Dai CY, Huang JF, Chiu CF, Yang YH, Hou NJ, Lee LP, Hsieh MY, Lin ZY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology. 2008 Jun;47(6):1884-93. doi: 10.1002/hep.22319.
PubMed 18508296
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Labeled, Active-Controlled Trial of 24-Week Versus 48-Week Courses of Peg-Interferon Alpha Plus Ribavirin for Genotype-1 Infected Chronic Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT00629967
- Acronym / sponsor ID
- KMUH-IRB-94045
- Conditions
- Chronic Hepatitis C, Genotype
- Keywords
- chronic hepatitis C, genotype 1, rapid virological response, sustained virological response, peginterferon, ribavirin, treatment duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 6 Mar 2008 (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 purposes of this study are:
- To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve a sustained virological response (SVR) rate comparable to that observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype 1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week 4) at 4 weeks.
- To investigate the role of on-treatment virological responses among patients with 24 or 48 weeks treatment.
Detailed description
Peginterferon and ribavirin combination treatment has been recommended for all patients infected with HCV, but the treatment duration varies depending on the HCV genotype. Recommended treatment for patients with HCV-1 infection is pegylated interferon plus ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR. Previous studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter duration of treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as effective as a 24-week treatment regimen. These findings have questioned whether shorter treatment duration can yield high SVR rates for HCV-1 pts with an RVR.
The primary aim of the present study is to evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.
The secondary aim is to investigate the role of on-treatment virologic responses among patients with 24 or 48 weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: pegylated interferon alpha 2a and ribavirinEligible patients will be randomized into two groups with a ratio of 1:1 (Arm A \& B) |
| B | Active comparator | Drug: Pegylated interferon alfa-2a and ribavirinEligible patients will be randomized into two groups with a ratio of 1:1 (Arm A \& B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients, 18-65 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA and HCV viral genotype 1
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Key exclusion criteria (20 listed)
- Women with ongoing pregnancy or breast feeding
- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, 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)
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 2a and ribavirinAlso: PEGASYS®pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks | Drug | A |
| Pegylated interferon alfa-2a and ribavirinAlso: PEGASYS®Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks | Drug | B |
Primary outcome
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Time frame: 2 years
3 secondary outcomes
Safety - adverse event rate and profile
Time frame: 2 years
Early virological response (EVR), by PCR-negative or 2 logs decline from baseline at week 12
Time frame: 2 years
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Time frame: 2 years
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 6 Mar 2008.
- Background: PubMed 15558712Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
- Background: PubMed 15057920Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
- Background: PubMed 14996676Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.
- Background: PubMed 12324553Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.
- Derived from this study: PubMed 18508296Yu ML, Dai CY, Huang JF, Chiu CF, Yang YH, Hou NJ, Lee LP, Hsieh MY, Lin ZY, Chen SC, Hsieh MY, Wang LY, Chang WY, Chuang WL. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology. 2008 Jun;47(6):1884-93. doi: 10.1002/hep.22319.
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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.
Ming-Lung Yu, MD, PhD principal investigator
Kaohsiung Medical University
Chia-Yen Dai, MD, Ms principal investigator
Kaohsiung Municipal Hsiao-Kang Hospital
Chang-Fu Chiu, MD principal investigator
Paochien Hospital
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 pegylated interferon alpha 2a and ribavirin and Pegylated interferon alfa-2a and ribavirin in people with Chronic Hepatitis C and Genotype, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 10 inclusion and 20 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 6 Mar 2008. 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 Taiwan. 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?
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period. (time frame: 2 years). 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 NCT00629967, which also lists 5 linked publications.
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 6 Mar 2008.