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GS-9256

Phase 2

HCV Infection | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: May 31, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

GS-9256 · 1 trial · 1 indication

Phase 2 1
NCT01072695Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus InfectionHCV Infection
COMPLETED46 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects achieving rapid virologic response (RVR)
Day 28
AEs, physical examination and clinical laboratory test findings, vital signs, ECGs
Throughout first six weeks of study

Secondary Endpoints

Plasma pharmacokinetics
Throughout Day 28
Viral resistance
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -

Interventions

NameTypeDescription
GS-9256DRUG75 mg BID x 28 days
GS-9190DRUG40 mg BID x 28 days
RibavirinDRUG1000-1200 mg/day given BID
Peginterferon alfa-2aDRUG180 ug q week
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adult subjects, ages 18-70 * Willing able to provide informed consent * BMI between 18 and 36 kg/m2 (inclusive) * Chronic HCV infection, genotype 1 * HCV RNA \>/= 3 log, but \< 7.2 log10 IU/ml at screen * Liver biopsy, FibroTest, or FibroScan indicating absence of cirrhosis * ...

Countries:BelgiumFranceGermanyUnited Kingdom
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Frequently asked questions about GS-9256

What is GS-9256 used for?

GS-9256 is an investigational small molecule being developed for the treatment of HCV Infection, specifically chronic hepatitis C virus infection. It is a Phase 2 investigational drug and is not yet approved for use.

Who makes GS-9256?

GS-9256 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HCV infection.

What phase is GS-9256 in?

GS-9256 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is GS-9256 in?

GS-9256 has been studied in one completed Phase 2 clinical trial, identified as NCT01072695. This trial evaluated GS-9256 in combination with GS-9190, with or without ribavirin, for 28 days in patients with chronic hepatitis C virus infection. The trial enrolled 46 participants across Belgium, France, Germany, and the United Kingdom.

Is GS-9256 the same as GS-9190?

No, GS-9256 is not the same as GS-9190. They are two distinct investigational drugs developed by Gilead Sciences. In the clinical trial NCT01072695, GS-9256 was studied alone and in combination with GS-9190, with or without ribavirin, to assess their effects in patients with chronic hepatitis C virus infection.