Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatitis, Chronic; Hepatitis C Virus

Treatments: Drug: Small Molecule Agent (PF-868554)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00671671

A8121006

Details and patient eligibility

About

Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HCV Positive With HCV RNA>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

Exclusion criteria

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP>200ng/ml

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Cohort B

Experimental group

Treatment:

Drug: Small Molecule Agent (PF-868554)

Drug: Small Molecule Agent (PF-868554)

Cohort A

Experimental group

Description:

Dose study drug in subjects who have previously failed to respond to interferon based therapies

Treatment:

Drug: Small Molecule Agent (PF-868554)

Drug: Small Molecule Agent (PF-868554)