Clinical trial NCT00720434: A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Official title: A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set
timeFrame: Baseline, Week 4
measure: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
timeFrame: Week 4, 12, 48, 60, 72
measure: Alanine Aminotransferase (ALT) Levels
timeFrame: Week 4, 12, 48, 72
measure: Population Pharmacokinetics (PK) of PF-00868554
timeFrame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Santurce
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: