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High ribavirin dose

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 11, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

High ribavirin dose · 1 trial · 1 indication

Phase 2 1
NCT00944684High Dose Ribavirin in the Treatment of Chronic Hepatitis CChronic Hepatitis C
COMPLETED32 Analytics
PHASE2COMPLETED
High Dose Ribavirin in the Treatment of Chronic Hepatitis C
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Sustained virological response
1 Day

Secondary Endpoints

Adverse Events
day 1 until 24 weeks after end or treatment
Rapid virological response at 4 weeks of treatment
4 weeks
Early virological response at 12 weeks of treatment
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALPegIFN-alpha 2a + RBV (commenced according to kidney function) adjusted to plasma levels. Treatment with erythropoetin 3x3,000IU/week up to 3x10,000IU/week in case of hemolytic anemia
BACTIVE_COMPARATORPegIFN-alpha 2a + RBV (weight based; 1,000 or 1,200 mg/day)

Interventions

NameTypeDescription
High ribavirin doseDRUGRibavirin dose started according to kidney function (usually 1,800mg) and adapted according to plasma level during follow-up
Standard ribavirin doseDRUGRibavirin dose started at 1,000mg (body weight \<65kg) or 1,200mg (body weight equal or \>65kg)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male and female patients aged 18-65 years * Elevated liver enzymes levels * Compensated liver disease * Available liver histology confirming METAVIR F2 fibrosis * Written consent to participation Exclusion Criteria * Age \<18, \>65 * Prior ribavirin treatment * Intolerance t...

Countries:Switzerland
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Frequently asked questions about High ribavirin dose

What is High ribavirin dose used for?

High ribavirin dose is used for the treatment of chronic hepatitis C. It is an investigational small molecule being studied in Phase 2 clinical trials for this infectious disease. The drug is being developed by Roche Holding AG (RHHBY).

How does High ribavirin dose work?

High ribavirin dose is a small molecule antiviral. While the exact mechanism is not specified, ribavirin is known to interfere with viral RNA replication. It is being studied in combination with other antiviral agents for chronic hepatitis C.

Who makes High ribavirin dose?

High ribavirin dose is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic hepatitis C.

What phase is High ribavirin dose in?

High ribavirin dose is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total enrollment of 80 participants.

What clinical trials is High ribavirin dose in?

High ribavirin dose has been studied in two completed Phase 2 trials: NCT00944684, which evaluated high dose ribavirin in chronic hepatitis C, and NCT01482390, which studied mericitabine in combination with telaprevir and peginterferon alfa-2a/ribavirin. Both trials are completed.

Is High ribavirin dose the same as ribavirin?

High ribavirin dose refers to a higher dose of ribavirin, an antiviral medication. It is not a distinct drug but a dosing strategy. The trials listed include studies of ribavirin at higher doses, such as NCT00944684, which specifically investigated high dose ribavirin.