RANDOMIZED, DOUBLE–BLIND, MULTICENTER STUDY TO COMPARE THE SAFETY AND EFFICACY OF VIRAMIDINE TO RIBAVIRIN IN TREATMENT–NAïVE PATIENTS WITH CHRONIC HEPATITIS C

Phase 1

• Conditions: Chronic Hepatitis C Viral Infection; MedDRA version: 5.1Level: LLTClassification code 10008912

• Registration Number: EUCTR2004-000408-41-GB
• Lead Sponsor: Ribapharm, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Treatment–naïve patients with compensated chronic hepatitis C.

2. HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe neuropsychiatric disorders

2. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease

3. Pregnant or breast-feeding patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified