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Viramidine

Phase 3

Chronic Hepatitis C | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Jun 22, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,800

FDA Designations

No designations recorded

Clinical trial landscape

Viramidine · 2 trials · 1 indication

Phase 3 2
NCT00093093Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment NaiveChronic Hepatitis C
COMPLETED900 Analytics
NCT00230958Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-NaiveChronic Hepatitis C
COMPLETED900 Analytics
PHASE3COMPLETED
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
Chronic Hepatitis CUnlock trial analytics
PHASE3COMPLETED
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
- Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.

Secondary Endpoints

- Efficacy: Undetectable plasma HCV RNA at treatment week 24
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
- Safety: Monitoring of adverse events
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ViramidineDRUG -
RibavirinDRUG -
pegylated interferon alfa-2aDRUG -
pegylated interferon alfa-2bDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites100

Inclusion Criteria: * Treatment-naive patients with compensated chronic hepatitis C. * HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria: * Severe neuropsychiatric diso...

Countries:United StatesArgentinaAustraliaCanadaFranceIsraelItalyPolandPuerto RicoRussiaSpainUnited Kingdom
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Frequently asked questions about Viramidine

What is Viramidine used for?

Viramidine is an investigational small molecule being studied for the treatment of chronic Hepatitis C. It is a nucleoside analogue that was evaluated in Phase 3 clinical trials as a potential alternative to ribavirin in patients with chronic Hepatitis C who are treatment naive.

Who makes Viramidine?

Viramidine is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC on the stock market. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis C.

What phase is Viramidine in?

Viramidine is in Phase 3 clinical development. It has completed two Phase 3 trials, but it is not yet approved by regulatory authorities. The drug remains investigational and is not available for commercial use.

What clinical trials is Viramidine in?

Viramidine has been studied in two completed Phase 3 clinical trials. The first trial, NCT00093093, enrolled 900 treatment-naive patients with chronic Hepatitis C across multiple countries. The second trial, NCT00230958, also enrolled 900 treatment-naive patients with the same condition.

Is Viramidine the same as ribavirin?

No, Viramidine is not the same as ribavirin, but it was studied as a comparison to ribavirin in clinical trials. Both are small molecules used for chronic Hepatitis C, but Viramidine is a distinct investigational compound being evaluated as a potential alternative.