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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Genotype-1 Relapse

Treatments: Drug: Placebo BID + SOC; Drug: NIM811

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983060

CNIM811B2202

EUDRACT number: 2009-009995-11

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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
• Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

NIM811

Experimental group

Treatment:

Drug: NIM811

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo BID + SOC