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Peg-interferon alpha-2a, Ribavirin

Phase 2

Chronic Hepatitis C | Small molecule | Other |Roche Holding AG|Trials Updated: Feb 26, 2014

Peg-interferon alpha-2a, Ribavirin target and mechanism

ModalitySmall molecule

Also known as Peg-interféron alpha-2a (PEGASYS), Ribavirin (COPEGUS)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Peg-interferon alpha-2a, Ribavirin clinical trials

Peg-interferon alpha-2a, Ribavirin · 1 trial · 1 indication

Phase 2 1
NCT01289496Ribavirin Dose Optimization for the Treatment of Hepatitis CChronic Hepatitis C
COMPLETED13 Analytics
PHASE2COMPLETED
Ribavirin Dose Optimization for the Treatment of Hepatitis C
Chronic Hepatitis C
NCT0128949613
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Study Endpoints

Primary Endpoints

Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
up to 24 weeks post treatment

Qualitative

Secondary Endpoints

Viral Kinetics
up to 24 weeks post treatment
Neutrophils
up to 24-48 weeks of treatment
Hemoglobin
up to 24-48 weeks of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Peg-interferon alpha-2a, RibavirinEXPERIMENTALAdult patients with chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin(non-response or relapse). This is a pilot study with no control group.

Interventions

NameTypeDescription
Peg-interferon alpha-2a, RibavirinDRUG* 4 weeks RBV priming; * 24 or 48 weeks of Pegasys+Ribavirin (RBV) Treatment (depending on genotype); * 24 weeks Follow-Up Patients will receive PEGASYS® 180 µg in 0.5 mL (prefilled syringes) administered sc once weekly. Specific guidelines for adjusting the dose of PEGASYS® are provided in the product monograph.All PEGASYS® administrations will be via the sc route using sterile technique. Ribavirin 200 mg tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age \> 18 years * Chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin (non-response: HCV-RNA decreased less than 2 logs after 3 months of treatment; relapse: HCV-RNA that becomes positive again after treatment is stopped * Compensated hepatic d...

Countries:Canada
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