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Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis, Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 carcinoma. For those subjects with an ultrasound conducted outside the 6-month time
window, an ultrasound must be performed prior to randomization.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00987337
Pfizer
Completed
Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects

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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
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.
Not Provided
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hepatitis
  • Hepatitis C
  • Drug: Filibuvir
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  • Drug: Filibuvir
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    - or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4)

    Intervention: Drug: Filibuvir
  • Experimental: Arm B

    Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

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    Intervention: Drug: Filibuvir
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    Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
January 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Hungary,   Korea, Republic of,   Puerto Rico,   Spain,   United States
 
 
NCT00987337
A8121014
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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