An Open-label, Randomized Pilot Study to Compare the Effectiveness of Peginterferon-alfa-2b Plus Ribavirin to Peginterferon-alfa-2b Plus Epoetin-alfa and Two Doses of Ribavirin in the Treatment of Chronic Hepatitis C Virus Infection
Overview
- Phase
- Phase 3
- Intervention
- Peginterferon-alpha-2b (PEG-Intron)
- Conditions
- Hepatitis C
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.
Detailed Description
Chronic infection with hepatitis C virus (HCV) leads to cirrhosis, hepatocellular carcinoma and liver failure. The treatment for end stage liver disease is hepatic transplantation. It is therefore important the patients with chronic HCV infection be recognized and treated before they develop advanced disease. The most effective therapy for patients with chronic HCV appears to be the combination of peginterferon-alpha-2b (PEG-Intron) plus ribavirin. Overall, 54% of patients treated with these medications achieve sustained virologic response. Response to therapy is greatly enhanced in those patients who can tolerate this therapy and remain on treatment without the need for dose reduction. The single most common reason for reducing the dose of ribavirin is anemia. Ribavirin causes a dose dependent hemolytic anemia and this side effect is believed to be exacerbated by the marrow suppressive effects of interferon. Preliminary studies have suggested that anemia can be overcome with the use of erythropoetin. The present pilot study will test the hypothesis that treatment with Epoetin-alph will allow patients with chronic HCV to utilize higher doses of ribavirin along with PEG-Intron therapy and that this will lead to a more rapid decline in HCV RNA titer and an increase in sustained virologic response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HCV RNA positive in serum
- •HCV genotype 1
- •Liver histology consistent with chronic HCV performed within 24 months prior to starting medication in this study
Exclusion Criteria
- •Previous interferon treatment
- •Any other cause for liver disease
- •Hemoglobin \>10 gm/dl
- •WBC \>3,000/cubic mm
- •Platelet count \> 80,000/cubic mm
- •Serum albumin \< 3.5 gm.dl
- •Conjugated serum bilirubin \> 2.0 mg/dl
- •INR \> 1.5
- •Positive HIV test
- •Refusal to use adequate contraception in female subjects or the spouse.sexual partners of male subjects
Arms & Interventions
1
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD
Intervention: Peginterferon-alpha-2b (PEG-Intron)
1
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD
Intervention: Ribavirin
2
PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Peginterferon-alpha-2b (PEG-Intron)
2
PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Ribavirin
2
PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Epoetin-alpha (Procrit)
3
PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Peginterferon-alpha-2b (PEG-Intron)
3
PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Ribavirin
3
PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Intervention: Epoetin-alpha (Procrit)
Outcomes
Primary Outcomes
The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.
Time Frame: 18 months
Secondary Outcomes
- Number of patients in each group who required a dose reduction of ribavirin(18 months)
- Rate of virologic response and sustained virologic response observed in each group(18 months)
- Rate of decline in HCV RNA titer in each group(18 months)