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valopicitabine

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 10, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

valopicitabine · 3 trials · 1 indication

Phase 2 2Phase 1 1
NCT00118768A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis CChronic Hepatitis C
COMPLETED175 Analytics
NCT00120861Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard TherapyChronic Hepatitis C
COMPLETED- Analytics
PHASE2COMPLETED
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
Chronic Hepatitis C
NCT00118768175
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PHASE2COMPLETED
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
Chronic Hepatitis C
NCT00120861-
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
valopicitabineDRUG -
Pegylated Interferon AlfaDRUG -
pegylated interferonDRUG -
ribavirinDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease * Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection) * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient i...

Countries:United StatesPuerto Rico
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Frequently asked questions about valopicitabine

What is valopicitabine used for?

Valopicitabine is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is a nucleoside analogue that was studied in combination with pegylated interferon alfa, as well as alone, in patients with this condition. The drug is not approved and remains in clinical development.

Who makes valopicitabine?

Valopicitabine is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored clinical trials evaluating the drug in patients with chronic Hepatitis C, including studies of the drug alone and in combination with pegylated interferon.

What phase is valopicitabine in?

Valopicitabine is in Phase 2 clinical development for chronic Hepatitis C. It has completed Phase 1 and Phase 2 trials, but no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has valopicitabine been in?

Valopicitabine has been studied in three completed clinical trials. NCT00118768 evaluated the drug with pegylated interferon alfa in 175 patients with Hepatitis C. NCT00120835 studied it alone and with interferon in treatment-naive patients. NCT00120861 assessed it alone and with pegylated interferon in patients who failed standard therapy.

Is valopicitabine the same as any other drug?

Valopicitabine is also known by other names, though specific alternative names are not listed here. It is a distinct investigational compound developed by Merck for chronic Hepatitis C. Patients and researchers should refer to the drug by its generic name to avoid confusion with other Hepatitis C treatments.