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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C Genotype-1 Relapse

In brief

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.

Key facts

Study ID

NCT00983060

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2009-09-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Novartis Investigative Site — Frankfurt, Germany
• Fundacion de Investigacion de Diego — San Juan, Puerto Rico
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Seville, Spain
• Novartis Investigative Site — Taipei, ROC, Taiwan
• Novartis Investigative Site — Kaohsiung City, Taiwan

Full record on ClinicalTrials.gov

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