A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

Tracking Information
First Submitted Date ICMJE	July 18, 2008
First Posted Date ICMJE	July 22, 2008
Results First Submitted Date	June 18, 2013
Results First Posted Date	August 26, 2013
Last Update Posted Date	August 26, 2013
Study Start Date ICMJE	August 2008
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 18, 2013)	Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set [ Time Frame: Baseline, Week 4 ]Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.; Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set [ Time Frame: Baseline, Week 4 ]Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Original Primary Outcome Measures ICMJE; (submitted: July 21, 2008)	To assess the antiviral activity of PF-00868554 in combination with pegIFN-a and RBV over four weeks [ Time Frame: 4 weeks ]
Change History	Complete list of historical versions of study NCT00720434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 18, 2013)	Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [ Time Frame: Week 4, 12, 48, 60, 72 ]Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.; Alanine Aminotransferase (ALT) Levels [ Time Frame: Week 4, 12, 48, 72 ]; Population Pharmacokinetics (PK) of PF-00868554 [ Time Frame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 ]Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Original Secondary Outcome Measures ICMJE; (submitted: July 21, 2008)	To assess the safety and tolerability of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ]; To assess the pharmacokinetics of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ]; To assess the effect of four weeks of PF-00868554 therapy on long-term response to pegIFN-a/RBV therapy. [ Time Frame: 72 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Official Title ICMJE	A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus
Brief Summary	The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Hepatitis C
Intervention ICMJE	Drug: PF-00868554 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.; Drug: PF-00868554 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; Drug: PF-00868554 200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; Drug: Placebo Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Study Arms	Experimental: A 500 mg BID Intervention: Drug: PF-00868554; Experimental: B 300 mg BID Intervention: Drug: PF-00868554; Experimental: C 200 mg BID Intervention: Drug: PF-00868554; Placebo Comparator: D Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* 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: April 6, 2010)	35
Original Estimated Enrollment ICMJE; (submitted: July 21, 2008)	40
Actual Study Completion Date	March 2010
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Treatment naive (no prior treatment with IFN-a +/- RBV regimens.; Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.; HCV RNA > 100,000 IU/mL at screening.; Genotype 1.; A diagnosis of chronic HCV infection for at least 6 months. Exclusion Criteria: Evidence of acute or chronic infection with HIV or HBV.; Exposure within the previous three months to an investigational anti-HCV agent.; Evidence of severe or decompensated liver disease.; Subjects with liver disease unrelated to HCV infection.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Puerto Rico, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00720434
Other Study ID Numbers ICMJE	A8121007
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Pfizer
Study Sponsor ICMJE	Pfizer
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP