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Safety, Tolerability and Efficacy of XTL 2125 in HCV-Infected Patients Who Are Interferon-Alpha Non-Responders or Relapsers

NCT00255359 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-11-06

No results posted yet for this study

Summary

The study will be a randomized, double blind, placebo controlled, dose rising study in Interferon alpha (IFN-alpha) non-responder HCV infected patients or HCV patients who have relapsed following IFN-alpha therapy. Eligible subjects must have compensated liver disease and serum HCV RNA concentrations above 100,000 IU/mL at screening. The study will include both a single dose period for the evaluation of acute toxicity and single dose pharmacokinetics and a consecutive multi-dose period for the determination of longer-term safety, multiple-dose pharmacokinetics and antiviral activity. The objectives of this study are to evaluate the safety, tolerability, and antiviral activity of escalating single and multiple doses of XTL 2125 in patients with chronic hepatitis C virus infection and to assess the single- and multiple-dose pharmacokinetics of XTL 2125

Conditions

  • Chronic Hepatitis C Virus Infection

Interventions

DRUG

XTL-2125

Sponsors & Collaborators

  • XTL Biopharmaceuticals

    collaborator INDUSTRY

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Eithan Galun, MD · Hadassah Medical Organization

  • Shlomo Dagan, PhD · XTL Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2007-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00255359 on ClinicalTrials.gov