Clinical trial NCT00987337: Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis
Hepatitis C
Keywords: Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 18 years of age.
* HCV seropositive.
* HCV RNA \>10,000 IU/mL at screening.
* HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
* Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents).
* Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
* Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP \>50 and \<100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.

Exclusion Criteria:

* Co-infection with either HIV or HBV.
* Evidence of severe or decompensated liver disease.
* Subjects with liver disease unrelated to HCV infection.
* Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Abnormal ECG suggestive of clinically significant cardiac disease or QTc\>450msec.
* History of organ transplant.
* Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up.
* Pregnant or nursing females.
* Males whose female partner is pregnant.

Primary outcomes:
measure: Percentage of Participants With Sustained Viral Response (SVR) at Week 72
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48
timeFrame: Week 4, 12, 24, 48
measure: Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)
timeFrame: 12 weeks after completion of therapy (Week 36 or 60)
measure: Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)
timeFrame: 24 weeks after completion of therapy (Week 48 or 72)
measure: Percentage of Participants With Breakthrough Viremia
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Relapsed Response
timeFrame: Week 24 or Week 48 up to Week 72
measure: Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24
timeFrame: Baseline, Week 4, 12, 24
measure: Number of Adverse Events (AEs) by Severity (All Causality)
timeFrame: Baseline up to Week 72
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)
timeFrame: Baseline up to Week 72
measure: Number of Participants Who Discontinued Study Due to Adverse Events (AEs)
timeFrame: Baseline up to Week 72
measure: Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)
timeFrame: Baseline up to Week 72
measure: Number of Participants With Laboratory Test Abnormalities by Severity
timeFrame: Baseline up to Week 72
measure: Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin
timeFrame: Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Coronado
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Mather
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Haine St. Paul
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Clichy
country: France
facility: Pfizer Investigational Site
city: Creteil cedex
country: France
facility: Pfizer Investigational Site
city: Marseille cedex 8
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 12
country: France
facility: Pfizer Investigational Site
city: Pessac Cedex
country: France
facility: Pfizer Investigational Site
city: Rennes cedex 9
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Bekescsaba
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Kaposvar
country: Hungary
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Rio Piedras
country: Puerto Rico
facility: Pfizer Investigational Site
city: Majadahonda
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.