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Clinical Trials/EUCTR2004-000408-41-GB
EUCTR2004-000408-41-GBActive, not recruitingPhase 1

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

Ribapharm, Inc.0 sites900 target enrollmentStarted: February 14, 2005Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
900
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
Ribapharm, Inc.

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