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Ribavirin

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Apr 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Ribavirin · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT01482390A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis CHepatitis C
COMPLETED80 Analytics
PHASE2COMPLETED
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
12 weeks after end of treatment (up to Week 60)
Pharmacokinetics: area under the plasma concentration time curve
Periods 1-4: Predose and up to 192 hours post-dose
Pharmacokinetics: maximum plasma concentration
Periods 1-4: Predose and up to 192 hours post-dose
Bioavailability
10 days

Secondary Endpoints

Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
4 weeks after end of treatment (up to Week 52)
Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
24 weeks after end of treatment (up to Week 72)
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
Weeks 2, 4, 12, 24, and 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)EXPERIMENTALTwelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)EXPERIMENTALTwelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)EXPERIMENTALTwelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)ACTIVE_COMPARATORTwelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
Crossover Period 1EXPERIMENTAL -
Crossover Period 2EXPERIMENTAL -
Crossover Period 3EXPERIMENTAL -
Crossover Period 4EXPERIMENTAL -
Ribavirin capsule armACTIVE_COMPARATOR -
Ribavirin tablet armEXPERIMENTAL -

Interventions

NameTypeDescription
RibavirinDRUGParticipants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
MericitabineDRUGParticipants will receive mericitabine 1000 mg orally twice daily.
Peginterferon Alfa-2aDRUGParticipants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
PlaceboDRUGParticipants will receive placebo matching to mericitabine orally twice daily.
TelaprevirDRUGParticipants will receive telaprevir 750 mg orally three times daily.
ribavirin [Copegus]DRUGtablet under fed condition
ribavirin [Vilona]DRUGSingle oral dose of a 400 mg capsule
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Chronic hepatitis C infection for at least 6 months duration * Hepatitis C genotype 1a or 1b * Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study * Participants showed a previous null response to therapy as defin...

Countries:United StatesCanadaFranceGermanyItalySpainUnited KingdomMexico
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about Ribavirin

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.