A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Placebo; Drug: PF-00868554

Study type: Interventional

Funder types: Industry

Identifiers

NCT00720434

A8121007

Details and patient eligibility

About

The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
• Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
• HCV RNA > 100,000 IU/mL at screening.
• Genotype 1.
• A diagnosis of chronic HCV infection for at least 6 months.

Exclusion criteria

• Evidence of acute or chronic infection with HIV or HBV.
• Exposure within the previous three months to an investigational anti-HCV agent.
• Evidence of severe or decompensated liver disease.
• Subjects with liver disease unrelated to HCV infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

500 mg BID

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

B

Experimental group

Description:

300 mg BID

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

C

Experimental group

Description:

200 mg BID

Treatment:

Drug: PF-00868554

Drug: PF-00868554

Drug: PF-00868554

D

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo