Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

NCT ID: NCT00575627

Last Updated: 2008-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-09-30

Brief Summary

Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT) levels have been generally excluded from treatment, because the strong conviction that normal ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; persistently normal ALT; pNNALT; Theraphy for Hepatitis C; Pegylated Interferon; Combined therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

Drug: peginterferon α-2a (40 kDa) plus ribavirin for 24-48 weeks

Group Type: EXPERIMENTAL

Peg-Interferon alpha2a plus Ribavirin

Intervention Type: DRUG

Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily

Interventions

Peg-Interferon alpha2a plus Ribavirin

Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Serologic evidence of chronic hepatitis C infection (repeatedly HCV-RNA positive) with persistent normal ALT levels documented on at least 3 occasions, in the last 18 months before screening.
• Fibroscan performed in the last 3 months
• Compensated liver disease, Child Pugh score <7
• Serum HCV-RNA >615 IU/mL
• Patients who are naïve to any hepatitis C therapy (i.e. have not been previously treated with an interferon or with IFN plus ribavirin)
• No clinical or radiological evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomisation
• 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
• History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease (Child Pugh B or C)
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug
• 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)
• 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
• Evidence of current severe psychiatric disease, especially depression within one year of study entry. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, within 12 months prior to study entry. Patients with a previous history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease should be evaluated by a qualified Psychiatrist for study suitability prior to enrolment.
• 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 6 months 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 <12 g/dL in women or <13 g/dL in men at screening
• Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Università degli Studi di Torino

Principal Investigators

Rizzetto Mario

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette,

Locations

Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette,

Torino, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

RIZZETTO Mario, MD

Role: CONTACT

Phone: +39-011-6336397

Email: m.rizzetto@molinette.piemonte.it

CIANCIO Alessia, MD, PhD

Role: CONTACT

Phone: +39-011-6336224

Email: aciancio3@molinette.piemonte.it

Facility Contacts

Ciancio Alessia, MD, PhD

Role: primary

Other Identifiers

NNALT

Identifier Type: -

Identifier Source: secondary_id

pNNALTHCV

Identifier Type: -

Identifier Source: org_study_id