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 - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00983060

Purpose

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	Intervention	Phase
Chronic Hepatitis C Genotype-1 Relapse	Drug: NIM811 Drug: Placebo BID + SOC	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

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 [ 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 ]

Enrollment:	59
Study Start Date:	September 2009
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983060

Locations

United States, California
Research and Education Inc.
San Diego, California, United States, 92105
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
University Hepatitis Center
Sarasota, Florida, United States, 34243
West Wind'r Research & Development LLC
Tampa, Florida, United States, 33607
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
Australia, New South Wales
Novartis Investigative Site
Clayton, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Australia, South Australia
Novartis Investigative Site
Wentworthville, South Australia, Australia
Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Frankfurt, Germany
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00909
Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Sevilla, Spain
Taiwan
Novartis Investigative Site
Taipei, ROC, Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00983060 History of Changes
Other Study ID Numbers:	CNIM811B2202, EUDRACT number: 2009-009995-11
Study First Received:	September 22, 2009
Last Updated:	November 3, 2011
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Switzerland: Swissmedic; Spain: Ministry of Health and Consumption; Australia: Human Research Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; Taiwan: Department of Health; Argentina: Human Research Bioethics Committee; China: State Food and Drug Administration

Keywords provided by Novartis:

NIM811
chronic hepatitis
chronic hepatitis C
chronic hepatitis C genotype-1

HCV
HCV-1
relapser

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012