Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00630084 |
Recruitment Status :
Completed
First Posted : March 6, 2008
Last Update Posted : September 4, 2015
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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 malignancy other than 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 malignancy other than hepatocellular carcinoma, compare to those without systemic malignancy.
- 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 malignancy other than hepatocellular carcinoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C Neoplasms | Drug: pegylated interferon alpha 2a and plus ribavirin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
40 naïve CHC patients concomitant with malignancy other than hepatocellular carcinoma
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Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other Name: PEGASYS® |
Active Comparator: B
80 naïve CHC patients without malignancy
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Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other Name: PEGASYS® |
- Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period. [ Time Frame: 1.5 year ]
- Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4. [ Time Frame: 1.5 year ]
- 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 year ]
- Safety - adverse event rate and profile [ Time Frame: 1.5 year ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients >18 years of age
- Local or Systemic malignancy other than hepatocellular carcinoma in remission or stable status
- 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
- 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
Exclusion Criteria:
- 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
- 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
- Evidence or history of hepatocellular carcinoma
- Local or Systemic malignancy unstable status

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630084
Taiwan | |
Kaohsiung Medical University Hospital | |
Kaohsiung, Taiwan, 807 |
Principal Investigator: | Ming-Lung Yu, MD, PhD | Kaohsiung Medical University |
Responsible Party: | Ming-Lung Yu, MD., PhD., Kaohsiung Medical University Chung-Ho Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00630084 |
Obsolete Identifiers: | NCT01006512 |
Other Study ID Numbers: |
KMUH-IRB-960044 |
First Posted: | March 6, 2008 Key Record Dates |
Last Update Posted: | September 4, 2015 |
Last Verified: | September 2015 |
chronic hepatitis C sustained virological response peginterferon ribavirin neoplasms |
Hepatitis A Hepatitis C Hepatitis C, Chronic Carcinoma, Hepatocellular Hepatitis Hepatitis, Chronic Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Interferons Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents |