Chronic Hepatitis CPhase 4NCT00834860

Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

A Phase 4 study testing peginterferon alpha-2a and ribavirin in people with Chronic Hepatitis C and Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C, Hepatocellular Carcinoma
What is being tested?: peginterferon alpha-2a and ribavirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 179 participants
Where: 1 siteTaiwan
Study dates: Jan 2007to Feb 2010
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

Male and female patients >18 years of age
Histopathological diagnosis of hepatocellular carcinoma >3 months before entry (Arm A)
Received curative therapies, including surgery, ablation therapy or liver transplantation >3 months before entry (ArmA)
No evidence of hepatocellular carcinoma by imaging or histopathological studies at entry
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

Show all 11Show fewer

Detectable serum HCV-RNA
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.)
Compensated liver disease (Child-Pugh Grade A clinical classification)
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
Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 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)
Clinical evidence of hepatocellular carcinoma

Show all 20Show fewer

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 at screening
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, 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>40 g/day) 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
Hgb <11 g/dL in women or <12 g/dL in men at screening
Any patient with major thalassemia
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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Medical University Hospital
Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular carcinoma deserve to be elucidated.

The purposes of this study are:

To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.
To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.

Read the detailed description

A prospective, hospital-based study enrolling 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma and other sex- and age-matched 100 chronic hepatitis C patients without malignancy will be conducted. The 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 100 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.

Conditions: Chronic Hepatitis C, Hepatocellular Carcinoma
Being tested: peginterferon alpha-2a and ribavirin
Keywords: chronic hepatitis C, sustained virological response, peginterferon, ribavirin, neoplasm
Medical subject headings: Hepatitis C, Chronic, Carcinoma, Hepatocellular, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

peginterferon alpha-2a and ribavirinDrug
Also called Pegasys and Robatrol
They received peginterferon alpha-2a (180 μg/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period.

Study groups in NCT00834860
Study group	Role	What they receive
CHC, HCC	Active comparator	100 naïve CHC patients concomitant with hepatocellular carcinoma without clinical evidence of HCC recurrence more than 3 months after curative treatments. Receives: Drug: peginterferon alpha-2a and ribavirin
CHC, LC	Active comparator	100 naïve CHC patients without malignancy Receives: Drug: peginterferon alpha-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: 1.5 years

Secondary outcomes (3)

Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Measured: 1.5 years
Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.
Measured: 1.5 years
Safety: adverse event rate and profile.
Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Feb 2010

First posted3 Feb 2009 (estimated)
Study startJan 2007
Primary completionDec 2009
Study completionFeb 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)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 Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00834860
Sponsor's protocol ID: KMUH-IRB-960043
Status last verified: Feb 2009
First submitted: 1 Feb 2009
Last updated: 15 Feb 2010
Results posted: No
Data monitoring committee: Yes

Publications

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
PubMed 11439948
Chuang WL, Chang WY, Lu SN, Su WP, Lin ZY, Chen SC, Hsieh MY, Wang LY, You SL, Chen CJ. The role of hepatitis B and C viruses in hepatocellular carcinoma in a hepatitis B endemic area. A case-control study. Cancer. 1992 Apr 15;69(8):2052-4. doi: 10.1002/1097-0142(19920415)69:83.0.co;2-n.
PubMed 1311978
Chuang WL, Yu ML, Dai CY, Chang WY. Treatment of chronic hepatitis C in southern Taiwan. Intervirology. 2006;49(1-2):99-106. doi: 10.1159/000087271.
PubMed 16166797
Yu ML, Dai CY, Chen SC, Lee LP, Huang JF, Lin ZY, Hsieh MY, Wang LY, Chuang WL, Chang WY. A prospective study on treatment of chronic hepatitis C with tailored and extended interferon-alpha regimens according to pretreatment virological factors. Antiviral Res. 2004 Jul;63(1):25-32. doi: 10.1016/j.antiviral.2004.01.002.
PubMed 15196817
McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.
PubMed 9819446
Fried 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 12324553
Chuang WL, Dai CY, Chen SC, Lee LP, Lin ZY, Hsieh MY, Wang LY, Yu ML, Chang WY. Randomized trial of three different regimens for 24 weeks for re-treatment of chronic hepatitis C patients who failed to respond to interferon-alpha monotherapy in Taiwan. Liver Int. 2004 Dec;24(6):595-602. doi: 10.1111/j.1478-3231.2004.0954.x.
PubMed 15566510
Yu ML, Lin SM, Chuang WL, Dai CY, Wang JH, Lu SN, Sheen IS, Chang WY, Lee CM, Liaw YF. A sustained virological response to interferon or interferon/ribavirin reduces hepatocellular carcinoma and improves survival in chronic hepatitis C: a nationwide, multicentre study in Taiwan. Antivir Ther. 2006;11(8):985-94.
PubMed 17302368
Huang JF, Yu ML, Lee CM, Dai CY, Hou NJ, Hsieh MY, Wang JH, Lu SN, Sheen IS, Lin SM, Chuang WL, Liaw YF. Sustained virological response to interferon reduces cirrhosis in chronic hepatitis C: a 1,386-patient study from Taiwan. Aliment Pharmacol Ther. 2007 May 1;25(9):1029-37. doi: 10.1111/j.1365-2036.2007.03297.x.
PubMed 17439503
Huang JF, Yeh ML, Yu ML, Dai CY, Huang CF, Huang CI, Tsai PC, Lin PC, Chen YL, Chang WT, Hou NJ, Lin ZY, Chen SC, Chuang WL. The tertiary prevention of hepatocellular carcinoma in chronic hepatitis C patients. J Gastroenterol Hepatol. 2015 Dec;30(12):1768-74. doi: 10.1111/jgh.13012.
PubMed 26094738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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RecruitingObservational study
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Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
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Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT00834860
Acronym / sponsor ID: KMUH-IRB-960043
Conditions: Chronic Hepatitis C, Hepatocellular Carcinoma
Keywords: chronic hepatitis C, sustained virological response, peginterferon, ribavirin, neoplasm
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 179 participants (actual)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
Study start: Jan 2007
Primary completion: Dec 2009 (actual)
Study completion: Feb 2010 (estimated)
First posted: 3 Feb 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 purposes of this study are:

To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.
To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CHC, HCC	Active comparator	Drug: peginterferon alpha-2a and ribavirin100 naïve CHC patients concomitant with hepatocellular carcinoma without clinical evidence of HCC recurrence more than 3 months after curative treatments.
CHC, LC	Active comparator	Drug: peginterferon alpha-2a and ribavirin100 naïve CHC patients without malignancy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male and female patients >18 years of age
Histopathological diagnosis of hepatocellular carcinoma >3 months before entry (Arm A)
Received curative therapies, including surgery, ablation therapy or liver transplantation >3 months before entry (ArmA)
No evidence of hepatocellular carcinoma by imaging or histopathological studies at entry
Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Key exclusion criteria (20 listed)

Women with ongoing pregnancy or breast feeding
Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 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
peginterferon alpha-2a and ribavirinAlso: Pegasys and RobatrolThey received peginterferon alpha-2a (180 μg/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period.	Drug	CHC, HCC, CHC, LC

Primary outcome

Efficacy: sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Time frame: 1.5 years

3 secondary outcomes

Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Time frame: 1.5 years
Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.
Time frame: 1.5 years
Safety: adverse event rate and profile.
Time frame: 1.5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
Background: PubMed 11439948Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
Background: PubMed 1311978Chuang WL, Chang WY, Lu SN, Su WP, Lin ZY, Chen SC, Hsieh MY, Wang LY, You SL, Chen CJ. The role of hepatitis B and C viruses in hepatocellular carcinoma in a hepatitis B endemic area. A case-control study. Cancer. 1992 Apr 15;69(8):2052-4. doi: 10.1002/1097-0142(19920415)69:83.0.co;2-n.
Background: PubMed 16166797Chuang WL, Yu ML, Dai CY, Chang WY. Treatment of chronic hepatitis C in southern Taiwan. Intervirology. 2006;49(1-2):99-106. doi: 10.1159/000087271.
Background: PubMed 15196817Yu ML, Dai CY, Chen SC, Lee LP, Huang JF, Lin ZY, Hsieh MY, Wang LY, Chuang WL, Chang WY. A prospective study on treatment of chronic hepatitis C with tailored and extended interferon-alpha regimens according to pretreatment virological factors. Antiviral Res. 2004 Jul;63(1):25-32. doi: 10.1016/j.antiviral.2004.01.002.
Background: PubMed 9819446McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.
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.
Background: PubMed 15566510Chuang WL, Dai CY, Chen SC, Lee LP, Lin ZY, Hsieh MY, Wang LY, Yu ML, Chang WY. Randomized trial of three different regimens for 24 weeks for re-treatment of chronic hepatitis C patients who failed to respond to interferon-alpha monotherapy in Taiwan. Liver Int. 2004 Dec;24(6):595-602. doi: 10.1111/j.1478-3231.2004.0954.x.
Background: PubMed 17302368Yu ML, Lin SM, Chuang WL, Dai CY, Wang JH, Lu SN, Sheen IS, Chang WY, Lee CM, Liaw YF. A sustained virological response to interferon or interferon/ribavirin reduces hepatocellular carcinoma and improves survival in chronic hepatitis C: a nationwide, multicentre study in Taiwan. Antivir Ther. 2006;11(8):985-94.
Background: PubMed 17439503Huang JF, Yu ML, Lee CM, Dai CY, Hou NJ, Hsieh MY, Wang JH, Lu SN, Sheen IS, Lin SM, Chuang WL, Liaw YF. Sustained virological response to interferon reduces cirrhosis in chronic hepatitis C: a 1,386-patient study from Taiwan. Aliment Pharmacol Ther. 2007 May 1;25(9):1029-37. doi: 10.1111/j.1365-2036.2007.03297.x.
Derived from this study: PubMed 26094738Huang JF, Yeh ML, Yu ML, Dai CY, Huang CF, Huang CI, Tsai PC, Lin PC, Chen YL, Chang WT, Hou NJ, Lin ZY, Chen SC, Chuang WL. The tertiary prevention of hepatocellular carcinoma in chronic hepatitis C patients. J Gastroenterol Hepatol. 2015 Dec;30(12):1768-74. doi: 10.1111/jgh.13012.

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
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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.

Wan-Long Chuang, MD principal investigator

Kaohsiung Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: status not confirmed, as of the sponsor's last update on 15 Feb 2010. 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?

Results are not available in the source record.

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: 1.5 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 NCT00834860, which also lists 10 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 15 Feb 2010.