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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000408-41-GB

Enrollment

900

Registered

2005-02-14

Start date

2004-10-07

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Viral Infection MedDRA version: 5.1 Level: LLT Classification code 10008912

Interventions

Product Name: Viramidine Product Code: RNA003142 Pharmaceutical Form: Film-coated tablet CAS Number: 40372-00-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa–2a to treatment–naïve patients with chronic hepatitis C (CHC).;Secondary Objective: The determination of the population pharmacokinetics of viramidine and ribavirin. ;Primary end point(s): The primary safety endpoint will be the proportion of patients with hemoglobin <10 g/dL at any time during treatment or = 2.5 g/dL drop from baseline. The primary efficacy endpoint is undetectable serum HCV RNA (<100 copies/mL) at the end of the 24 week post–treatment follow–up period.	—

Measure

Time frame

Main Objective: Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa–2a to treatment–naïve patients with chronic hepatitis C (CHC).;Secondary Objective: The determination of the population pharmacokinetics of viramidine and ribavirin. ;Primary end point(s): The primary safety endpoint will be the proportion of patients with hemoglobin <10 g/dL at any time during treatment or = 2.5 g/dL drop from baseline. The primary efficacy endpoint is undetectable serum HCV RNA (<100 copies/mL) at the end of the 24 week post–treatment follow–up period.

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Countries

Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026