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Chapter 3.1<br />

128<br />

METHODS<br />

Study design<br />

Japanese academic hospitals and major general hospitals were invited to participate in<br />

the study. Additional entry criteria were availability of data on previous treatment with<br />

interferon and on clinical outcomes.<br />

All consecutive chronic hepatitis C patients who received interferon alpha treatment<br />

between January 1, 1990 and December 31, 1995 and who did not show a sustained<br />

virological response were included. Sustained virological response was defi ned as normal<br />

alanine aminotransferase (ALT) and negative HCV-RNA at the end of treatment and<br />

six months thereafter.<br />

The ethics committees of all participating centers approved the protocol. In order to<br />

ensure privacy of the patients, the treating physician replaced patient names by a code<br />

before entry in the database.<br />

Patient selection<br />

Data of all consecutive patients with chronic hepatitis C with non-response to previous<br />

interferon treatment were collected. Data were collected on separate case record<br />

forms, one per patient, by the local investigator. The case record forms were sent to the<br />

co-ordination center in <strong>Rotterdam</strong>, where the data were entered in a central database.<br />

Before the data were entered, they were checked and in case of doubt, contact was<br />

made with the local investigator.<br />

Data recorded<br />

Information was obtained on demographics (age, gender) and on details of the interferon<br />

treatment (starting date, duration, and total dose) as well as the glycyrrhizin treatment<br />

(starting date, duration, total dose). Virological data (genotype, viremia), hematological<br />

(platelet count) and biochemical data (aminotransferase levels, bilirubin, and gamma<br />

glutamyltransferase) were measured in the certifi ed laboratories of the participating<br />

hospitals and added to the case record form by the local investigator. Centrally, the<br />

results were corrected for local normal values.<br />

Follow-up data were recorded every four weeks if available and included ALT-levels, start<br />

of glycyrrhizin treatment and the occurrence of HCC. Patients were considered to have<br />

a HCC if biopsy proved so or if ultrasound or computed tomography showed a focal<br />

lesion in the presence of a serum alpha-fetoprotein of > 400.

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