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

Primary Purpose

Hepatitis, Hepatitis C

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Filibuvir

Placebo

About this trial

This is an interventional treatment trial for Hepatitis focused on measuring Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm C

Arm 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)

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

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.

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.

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.

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.

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.

Number of Participants Who Discontinued Study Due to Adverse Events (AEs)

Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)

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.

Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin

Full Information

NCT ID

NCT00987337

First Posted

September 29, 2009

Last Updated

December 10, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00987337

Brief Title

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

Acronym

FITNESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis, Hepatitis C

Keywords

Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

288 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Arm Title

Arm C

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Filibuvir

Intervention Description

300 mg BID

Intervention Type

Drug

Intervention Name(s)

Filibuvir

Intervention Description

600 mg BID

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

BID

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 72

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 4, 12, 24, 48

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Percentage of Participants With Breakthrough Viremia

Description

Time Frame

Baseline up to Week 48

Title

Percentage of Participants With Relapsed Response

Description

Time Frame

Week 24 or Week 48 up to Week 72

Title

Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24

Description

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.

Time Frame

Baseline, Week 4, 12, 24

Title

Number of Adverse Events (AEs) by Severity (All Causality)

Description

Time Frame

Baseline up to Week 72

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)

Description

Time Frame

Baseline up to Week 72

Title

Number of Participants Who Discontinued Study Due to Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 72

Title

Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 72

Title

Number of Participants With Laboratory Test Abnormalities by Severity

Description

Time Frame

Baseline up to Week 72

Title

Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92802

Country

United States

Facility Name

Pfizer Investigational Site

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Pfizer Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Pfizer Investigational Site

City

Mather

State/Province

California

ZIP/Postal Code

95655

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95814

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Pfizer Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Pfizer Investigational Site

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Pfizer Investigational Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Pfizer Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Pfizer Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114-2622

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

22713

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Haine St. Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 3V9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 4B9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z2C7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4P9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 2P4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

Pfizer Investigational Site

City

Creteil cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille cedex 8

ZIP/Postal Code

13285

Country

France

Facility Name

Pfizer Investigational Site

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Pfizer Investigational Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Pfizer Investigational Site

City

Vandoeuvre Les Nancy Cedex

ZIP/Postal Code

54511

Country

France

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duesseldorf

ZIP/Postal Code

40237

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kiel

ZIP/Postal Code

24146

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1126

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Rio Piedras

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28220

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Pfizer Investigational Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24927607

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121014&StudyName=Filibuvir%20In%20Treatment%20Naive%20Hepatitis%20C%20Virus%20%28HCV%29%20Genotype%201%20Subjects

Description

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

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

Hepatitis, Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial