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

NCT00987337

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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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 <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
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.

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Hepatitis, Hepatitis CFilibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
NCT00987337
  1. Anaheim, California
  2. Anaheim, California
  3. Coronado, California
  4. La Jolla, California
  5. Mather, California
  6. Sacramento, California
  7. Sacramento, California
  8. San Diego, California
  9. Aurora, Colorado
  10. Englewood, Colorado
  11. DeLand, Florida
  12. Jacksonville, Florida
  13. Jacksonville, Florida
  14. Orlando, Florida
  15. Orlando, Florida
  16. South Miami, Florida
  17. Winter Park, Florida
  18. Chicago, Illinois
  19. Indianapolis, Indiana
  20. New Orleans, Louisiana
  21. Boston, Massachusetts
  22. New York, New York
  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Philadelphia, Pennsylvania
  26. Nashville, Tennessee
  27. Houston, Texas
  28. San Antonio, Texas
  29. Salt Lake City, Utah
  30. Richmond, Virginia
  31. Bruxelles,
  32. Bruxelles,
  33. Edegem,
  34. Gent,
  35. Haine St. Paul,
  36. Leuven,
  37. Edmonton, Alberta
  38. Edmonton, Alberta
  39. Edmonton, Alberta
  40. Vancouver, British Columbia
  41. Vancouver, British Columbia
  42. Halifax, Nova Scotia
  43. Halifax, Nova Scotia
  44. Montreal, Quebec
  45. Montreal, Quebec
  46. Montreal, Quebec
  47. Clichy,
  48. Creteil cedex,
  49. Marseille cedex 8,
  50. Paris Cedex 12,
  51. Pessac Cedex,
  52. Rennes cedex 9,
  53. Vandoeuvre Les Nancy Cedex,
  54. Berlin,
  55. Bonn,
  56. Duesseldorf,
  57. Hamburg,
  58. Hamburg,
  59. Kiel,
  60. Koeln,
  61. Bekescsaba,
  62. Budapest,
  63. Debrecen,
  64. Gyula,
  65. Kaposvar,
  66. Seoul,
  67. Seoul,
  68. Seoul,
  69. Rio Piedras,
  70. Majadahonda, Madrid
  71. Barcelona,
  72. Barcelona,
  73. Cordoba,
  74. Madrid,
  75. Madrid,
  76. Madrid,
  77. Sevilla,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis
  • Hepatitis C
Intervention  ICMJE
  • Drug: Filibuvir
    300 mg BID
  • Drug: Filibuvir
    600 mg BID
  • Drug: Placebo
    BID
Study Arms  ICMJE
  • Experimental: Arm A

    Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)

    - 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)

    - or - Filibuvir 600 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
  • Placebo Comparator: Arm C
    Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2009)
288
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Hungary,   Korea, Republic of,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00987337
Other Study ID Numbers  ICMJE A8121014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP