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 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 22, 2009

Last Updated Date

November 3, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC (Part 1 only) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00983060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 [ Time Frame: 3 weeks, 5 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12) [ Time Frame: 12 weeks after cessation of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To evaluate the safety and efficacy of NIM811 dosed daily for 12 weeks in a population of HCV-1 infected, SOC relapser patients (Part 2) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response at the 12th week of dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 [ Time Frame: 3 weeks, 5 weeks, 13 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 24 weeks after cessation of treatment (SVR24) [ Time Frame: 24 weeks after cessation of treatment ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis C Genotype-1 Relapse

Intervention ^ICMJE

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)

Study Arms

Experimental: NIM811
Intervention: Drug: NIM811
Placebo Comparator: Placebo
Intervention: Drug: Placebo BID + SOC

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00983060

Other Study ID Numbers ^ICMJE

CNIM811B2202, EUDRACT number: 2009-009995-11

Has Data Monitoring Committee

Responsible Party

( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP