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

Phase 2

Completed

• Conditions: Chronic Hepatitis C Genotype-1 Relapse
• Interventions: Drug: NIM811; Drug: Placebo BID + SOC

• Registration Number: NCT00983060
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2011-04
• Status Verified: 2017-02
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIM811	NIM811	-
Placebo	Placebo BID + SOC	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC	4 weeks

Secondary Outcome Measures

Name	Time	Method
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 assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC	4 weeks
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 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

Trial Locations

Locations (7)

Research and Education Inc.; 🇺🇸 San Diego, California, United States

University Hepatitis Center; 🇺🇸 Sarasota, Florida, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Novartis Investigative Site; 🇨🇳 Kaohsiung, Taiwan

Fundacion de Investigacion de Diego; 🇵🇷 San Juan, Puerto Rico

West Wind'r Research & Development LLC; 🇺🇸 Tampa, Florida, United States