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

NCT00987337 | Completed Phase 2 Results DMC

• 1 other identifier: A8121014
• Study Type: interventional
• Target: 288
• Locations: 9 countries
• Sites: 77

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.

Conditions

Hepatitis; Hepatitis C

Keywords

Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Viral Response (SVR) at Week 72

  For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 24 (End of Treatment \[EOT\]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (\<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.

  Week 72

Secondary Outcomes (12)

• Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48

  Week 4, 12, 24, 48

• Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)

  12 weeks after completion of therapy (Week 36 or 60)

• Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)

  24 weeks after completion of therapy (Week 48 or 72)

• Percentage of Participants With Breakthrough Viremia

  Baseline up to Week 48

• Percentage of Participants With Relapsed Response

  Week 24 or Week 48 up to Week 72

Study Arms (3)

Arm A

EXPERIMENTAL

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)

Drug: Filibuvir

Arm B

EXPERIMENTAL

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)

Drug: Filibuvir

Arm C

PLACEBO COMPARATOR

Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks

Drug: Placebo

Interventions

Filibuvir DRUG

300 mg BID

Arm A

Placebo DRUG

BID

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (77)

Pfizer Investigational Site

Anaheim, California, 92801, United States

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Anaheim, California, 92802, United States

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Coronado, California, 92118, United States

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La Jolla, California, 92037, United States

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Mather, California, 95655, United States

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Sacramento, California, 95814, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92123, United States

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Aurora, Colorado, 80045, United States

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Englewood, Colorado, 80113, United States

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DeLand, Florida, 32720, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32209, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32809, United States

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South Miami, Florida, 33143, United States

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Winter Park, Florida, 32789, United States

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Chicago, Illinois, 60611, United States

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Indianapolis, Indiana, 46202, United States

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New Orleans, Louisiana, 70112, United States

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Boston, Massachusetts, 02114-2622, United States

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New York, New York, 10021, United States

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Durham, North Carolina, 22713, United States

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Durham, North Carolina, 27710, United States

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Philadelphia, Pennsylvania, 19141, United States

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Nashville, Tennessee, 37205, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78234, United States

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Salt Lake City, Utah, 84132, United States

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Richmond, Virginia, 23249, United States

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Brussels, 1020, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Leuven, 3000, Belgium

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Edmonton, Alberta, T5H 3V9, Canada

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Edmonton, Alberta, T5H 4B9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6Z2C7, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Montreal, Quebec, H2L 4P9, Canada

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Montreal, Quebec, H2X 2P4, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Clichy, 92110, France

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Créteil, 94010, France

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Marseille, 13285, France

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Paris, 75571, France

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Pessac, 33604, France

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Rennes, 35033, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 12157, Germany

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Bonn, 53105, Germany

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Cologne, 50937, Germany

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Düsseldorf, 40237, Germany

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Hamburg, 20099, Germany

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Hamburg, 20246, Germany

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Kiel, 24146, Germany

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Békéscsaba, 5600, Hungary

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Budapest, 1126, Hungary

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Debrecen, 4032, Hungary

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Gyula, 5700, Hungary

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Kaposvár, 7400, Hungary

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Pfizer Investigational Site

Rio Piedras, 00927, Puerto Rico

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08035, Spain

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Córdoba, Cordoba, 14004, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28029, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28034, Spain

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Pfizer Investigational Site

Majadahonda, Madrid, 28220, Spain

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Pfizer Investigational Site

Seville, Sevilla, 41014, Spain

Location

Related Publications (1)

• 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.

  PMID: 24927607 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hepatitis; Hepatitis C

Interventions

filibuvir

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 27, 2014
• Results First Posted: January 27, 2014

Record last verified: 2013-12

Locations

US (30); HU (5); ES (8); BE (6); KR (3); PR (1); DE (7); FR (7); CA (10)