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pegylated interferon alpha2a

Phase 3

Chronic Hepatitis C | Small molecule | Other |Roche Holding AG|Last Updated: Apr 24, 2007

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

pegylated interferon alpha2a · 1 trial · 1 indication

Phase 3 1
NCT00158496Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)Chronic Hepatitis C
COMPLETED100 Analytics
PHASE3COMPLETED
Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)
Chronic Hepatitis C
NCT00158496100
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Study Endpoints

Primary Endpoints

- Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment

Secondary Endpoints

Evaluation of HCV RNA at 12 and 24 weeks
changes in HCV RNA load during treatment
Normalization of ALT during treatment and 24 weeks after the end of treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
pegylated interferon alpha2aDRUG -
ribavirinDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * HCV antibodies using a third generation test * HCV RNA positive by PCR * Liver biopsy in the past 18 months with METAVIR score over A2 and over or equal to F1, or over or equal A1 and over F2 * ALT over 1.5 time the normal range in the 24 weeks prior to inclusion (Week-28; W-2...

Countries:Egypt
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