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NIM811

Phase 2

Chronic Hepatitis C Genotype-1 Relapse | Small molecule | Infectious Disease |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

NIM811 · 1 trial · 1 indication

Phase 2 1
NCT00983060Adaptive-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 PatientsChronic Hepatitis C Genotype-1 Relapse
COMPLETED59 Analytics
PHASE2COMPLETED
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
Chronic Hepatitis C Genotype-1 RelapseUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NIM811EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NIM811DRUGBID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo BID + SOCDRUGPlacebo BID + SOC (PEG IFN and RBV)
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites16

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 documen...

Countries:United StatesAustraliaBelgiumGermanyPuerto RicoSpainTaiwan
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Frequently asked questions about NIM811

What is NIM811 used for?

NIM811 is an investigational small molecule being studied for the treatment of chronic Hepatitis C genotype-1 relapse. It is intended for patients who have relapsed after prior therapy. The drug is administered in combination with standard of care for this condition.

Who makes NIM811?

NIM811 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis C genotype-1 relapse.

What phase is NIM811 in?

NIM811 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. The Phase 2 trial has been completed.

What clinical trials is NIM811 in?

NIM811 has been studied in one completed Phase 2 clinical trial, identified as NCT00983060. This was a randomized, double-blind, placebo-controlled adaptive-design dose-finding study that evaluated the antiviral efficacy and safety of NIM811 combined with standard of care in relapsed Hepatitis C virus genotype-1 infected patients.

How does NIM811 work?

NIM811 is a small molecule that targets the Hepatitis C virus. It is designed to inhibit viral replication, thereby reducing the viral load in patients with chronic Hepatitis C genotype-1 relapse. The drug is intended to be used in combination with standard of care therapy.