Phase 1
N=20
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
Hepatitis, Chronic · Hepatitis C Virus
Bottom Line
View on ClinicalTrials.gov: NCT00671671 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set — 6.11; -0.45 log10 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Small Molecule Agent (PF-868554) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set |
6.11; -0.45 | — |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set |
6.11; -0.45 | — |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set |
6.39; -2.15 | — |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set |
6.39; -2.15 | — |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set |
-2.2; -2.3 | — |
| PRIMARY Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set |
-2.2; -2.3 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
140275.9; 198506.9; NA; 291172.4; 139239.7; NA | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
239697.9; 344075.5 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
346170.1 | — |
| SECONDARY Plasma Concentration at The End of Dosing Interval (Ctau) |
NA; 6572.0; 1435.2; NA | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
44688.1; 38734.5; NA; 50274.1; 42859.7; NA | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.750; 2.000; NA; 2.000; 1.000; NA | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
7.468 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00671671). 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.