Effectiveness of patient support programme for the treatment of hepatitis C

Completed

• Conditions: Infections and Infestations; Chronic hepatitis C; Hepatitis C virus

• Registration Number: ISRCTN12471415
• Lead Sponsor: Department of Health (Taiwan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Adult patients who have never received interferon and who had at least 2000 copies of HCV ribonucleic acid per ml (RNA/ml) of serum with polymerase chain reaction (PCR) assay, serum aspartate aminotransferase (AST) above the upper limit of normal within six months before entry into study and a liver biopsy result consistent with the diagnosis of chronic hepatitis C.

Exclusion Criteria

Patients with:
1. Neutropenia (<1500/ml of neutrophils)
2. Anemia (Hb <12g/dl of hemoglobin)
3. Thrombocytopenia (platelet <90000/ml)
4. Human immunodeficiency virus (HIV) infection
5. Decompensated liver disease
6. Serum creatinine >1.5 times the upper limit of normal
7. Poorly-controlled psychiatric disease
8. Unwilling to receive contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (absence of detectable HCV RNA at the end of follow-up with PCR assay)

Secondary Outcome Measures

Name	Time	Method
1. Serum alanine aminotransferase<br>2. Aspartate aminotransferase<br>3. Dropout rate (the number of patients who discontinued treatment prematurely or were lost to follow-up)