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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987337
Other study ID # A8121014
Secondary ID
Status Completed
Phase Phase 2
First received September 29, 2009
Last updated December 10, 2013
Start date November 2009
Est. completion date January 2012

Study information

Verified date December 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 288
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Filibuvir
300 mg BID
Filibuvir
600 mg BID
Placebo
BID

Locations

Country Name City State
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Haine St. Paul
Belgium Pfizer Investigational Site Leuven
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Vancouver British Columbia
France Pfizer Investigational Site Clichy
France Pfizer Investigational Site Creteil cedex
France Pfizer Investigational Site Marseille cedex 8
France Pfizer Investigational Site Paris Cedex 12
France Pfizer Investigational Site Pessac Cedex
France Pfizer Investigational Site Rennes cedex 9
France Pfizer Investigational Site Vandoeuvre Les Nancy Cedex
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bonn
Germany Pfizer Investigational Site Duesseldorf
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Kiel
Germany Pfizer Investigational Site Koeln
Hungary Pfizer Investigational Site Bekescsaba
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Debrecen
Hungary Pfizer Investigational Site Gyula
Hungary Pfizer Investigational Site Kaposvar
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Puerto Rico Pfizer Investigational Site Rio Piedras
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Cordoba
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Majadahonda Madrid
Spain Pfizer Investigational Site Sevilla
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Coronado California
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Englewood Colorado
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Mather California
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site South Miami Florida
United States Pfizer Investigational Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Korea, Republic of,  Puerto Rico,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48 Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL. Week 4, 12, 24, 48 No
Secondary Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12) A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized. 12 weeks after completion of therapy (Week 36 or 60) No
Secondary Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24) SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48). 24 weeks after completion of therapy (Week 48 or 72) No
Secondary Percentage of Participants With Breakthrough Viremia A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized. Baseline up to Week 48 No
Secondary Percentage of Participants With Relapsed Response A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized. Week 24 or Week 48 up to Week 72 No
Secondary Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24 Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements. Baseline, Week 4, 12, 24 No
Secondary Number of Adverse Events (AEs) by Severity (All Causality) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event. Baseline up to Week 72 Yes
Secondary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized. Baseline up to Week 72 Yes
Secondary Number of Participants Who Discontinued Study Due to Adverse Events (AEs) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Baseline up to Week 72 Yes
Secondary Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Baseline up to Week 72 Yes
Secondary Number of Participants With Laboratory Test Abnormalities by Severity Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening. Baseline up to Week 72 Yes
Secondary Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin 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 No
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