Phase 2
Completed N=35
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Source: ClinicalTrials.gov NCT00720434 ↗Enrolled (actual)
35
Serious AEs
14.3%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set — 6.38843; 6.67823; 6.66254; 6.42047 log10 IU/mL — p=0.0131
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set |
6.38843; 6.67823; 6.66254; 6.42047; -4.45887; -4.64646 | 0.0131 sig |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set |
-4.45887; -4.64646; -3.61918; -2.10239 | 0.0131 sig |
| SECONDARY Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
0.6000; 0.7500; 0.6250; 0.0000; 0.8000; 0.8750 | — |
| SECONDARY Alanine Aminotransferase (ALT) Levels |
31.1; 28.5; 51.6; 47.1; 32.9; 29.4 | — |
| SECONDARY Population Pharmacokinetics (PK) of PF-00868554 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
- Subjects who have discontinued IFN-a containing regimens after 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.
Data sourced from ClinicalTrials.gov (NCT00720434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.