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ANA598

Phase 2

HCV Infection | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Mar 31, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

ANA598 · 1 trial · 1 indication

Phase 2 1
NCT00978497Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV InfectionHCV Infection
COMPLETED97 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Undetectable HCV RNA
12 Weeks

Secondary Endpoints

Safety and Tolerability
Throughout study
Undetectable HCV RNA
Week 4, Week 24, and Week 48
ANA598, Peg-IFN-a-2-a, ribavirin concentrations
Various time points through Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORPeginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
2EXPERIMENTALANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks
3EXPERIMENTALANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks

Interventions

NameTypeDescription
placeboDRUGoral BID
ANA598DRUGoral 200mg BID
PeginterferonDRUG180 μg dose via subcutaneous injection weekly
RibavirinDRUGoral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female, ages 18 to 65 years * Documented chronic HCV infection, genotype 1a or 1b * Treatment-naïve Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Infection with non-genotype 1 HCV * Previous treatment for HCV infection * HIV or HBV positi...

Countries:United StatesPuerto Rico
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Frequently asked questions about ANA598

What is ANA598 used for?

ANA598 is an investigational small molecule being developed for the treatment of HCV infection, specifically genotype-1 chronic hepatitis C. It is intended to be used in combination with pegylated interferon and ribavirin, as evaluated in a Phase 2 clinical trial.

What does ANA598 target?

ANA598 is a small molecule antiviral agent. The specific molecular target is not disclosed in the available information. It is being studied for its antiviral activity against genotype-1 chronic HCV infection when administered with pegylated interferon and ribavirin.

Who makes ANA598?

ANA598 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for the treatment of HCV infection.

What phase is ANA598 in?

ANA598 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug, not yet approved by regulatory authorities. The completed trial evaluated its safety, tolerability, and antiviral activity in combination with standard therapy.

What clinical trials is ANA598 in?

ANA598 has one completed clinical trial, registered as NCT00978497. This Phase 2 study assessed the safety, tolerability, and antiviral activity of ANA598 in combination with pegylated interferon and ribavirin for genotype-1 chronic HCV infection. The trial enrolled 97 participants in the United States and Puerto Rico.

Is ANA598 the same as any other drug?

ANA598 is not known to have alternative names. It is an investigational small molecule developed by Roche Holding AG for the treatment of HCV infection, and it is distinct from other antiviral agents in its class.