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Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

NCT00983060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-12-19

No results posted yet for this study

Summary

This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.

Conditions

  • Chronic Hepatitis C Genotype-1 Relapse

Interventions

DRUG

NIM811

BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)

DRUG

Placebo BID + SOC

Placebo BID + SOC (PEG IFN and RBV)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Puerto Rico
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

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 NCT00983060 on ClinicalTrials.gov