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Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

NCT01200420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-01-31

No results posted yet for this study

Summary

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.

Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

Conditions

  • Hepatitis C

Interventions

DRUG

miravirsen

SC injection

DRUG

saline

SC injection

Sponsors & Collaborators

  • Santaris Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Stefan Zeuzem, MD · J.W. Goethe University Hospital, Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Germany
  • Netherlands
  • Poland
  • Puerto Rico
  • Slovakia

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 NCT01200420 on ClinicalTrials.gov