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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; Hepatitis

Treatments: Drug: Filibuvir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987337

A8121014

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 3 patient groups, including a placebo group

Arm A

Experimental group

Description:

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)

Treatment:

Drug: Filibuvir

Drug: Filibuvir

Arm B

Experimental group

Description:

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)

Treatment:

Drug: Filibuvir

Drug: Filibuvir

Arm C

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo