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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00983060

Collaborator

(none)

Enrollment

Locations

Arms

3.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Genotype-1 Relapse	Drug: NIM811 Drug: Placebo BID + SOC	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NIM811	Drug: NIM811 BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo Comparator: Placebo	Drug: Placebo BID + SOC Placebo BID + SOC (PEG IFN and RBV)

Arm

Intervention/Treatment

Experimental: NIM811

Drug: NIM811

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

Placebo Comparator: Placebo

Drug: Placebo BID + SOC

Placebo BID + SOC (PEG IFN and RBV)

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC [4 weeks]

Secondary Outcome Measures

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 [12 weeks]
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC [4 weeks]
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 [3 weeks, 5 weeks]
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) [12 weeks after cessation of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research and Education Inc.	San Diego	California	United States	92105
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809
3	University Hepatitis Center	Sarasota	Florida	United States	34243
4	West Wind'r Research & Development LLC	Tampa	Florida	United States	33607
5	Alamo Medical Research	San Antonio	Texas	United States	78215
6	Novartis Investigative Site	Clayton	New South Wales	Australia
7	Novartis Investigative Site	Westmead	New South Wales	Australia
8	Novartis Investigative Site	Wentworthville	South Australia	Australia
9	Novartis Investigative Site	Brussels		Belgium
10	Novartis Investigative Site	Leuven		Belgium	3000
11	Novartis Investigative Site	Frankfurt		Germany
12	Fundacion de Investigacion de Diego	San Juan		Puerto Rico	00909
13	Novartis Investigative Site	Barcelona		Spain
14	Novartis Investigative Site	Sevilla		Spain
15	Novartis Investigative Site	Taipei	ROC	Taiwan
16	Novartis Investigative Site	Kaohsiung		Taiwan