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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 | Clinical Trials | Clareo Health

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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

A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1

NCT00983060•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients eligible for inclusion in this study have to fulfill all of the following criteria:
•chronic hepatitis C genotype-1
•HCV-RNA should be ≥ 4 x 105 IU/mL at screening
•Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit

Exclusion Criteria

•Use of any HCV treatment ≤ 3months prior to study start
•Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
•Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
•Pregnant or breastfeeding women
•Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection
•Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets
•History of treatment for depression

Locations (16)

Research and Education Inc.

San Diego, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

University Hepatitis Center

Sarasota, Florida, United States

West Wind'r Research & Development LLC

Tampa, Florida, United States

Alamo Medical Research

San Antonio, Texas, United States

Novartis Investigative Site

Clayton, New South Wales, Australia

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Wentworthville, South Australia, Australia

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Leuven, Belgium

Key Dates

Start Date

September 1, 2009

Primary Completion Date

April 1, 2011

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C Genotype-1 Relapse

Interventions

NIM811

DRUG

Placebo BID + SOC

DRUG