Dose-Ranging Study of PSI-7977 in Combination With SOC in Treatment Naïve GT 1 HCV Patients - Full Text View

Purpose

This Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study will Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-7977 in Combination with Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1. Approximately 60 treatment-naive GT-1 HCV infected patients will be enrolled in three parallel cohorts. Each cohort will receive PSI-7977, ranging from 100mg to 400mg, or matching placebo tablets, on Days 0-28. Patients will also receive treatment with SOC (PEG-IFN and RBV) starting on Day 0 of this trial, and continuing for 48 weeks. Eligible patients will be randomized to one of the 3 active cohorts based upon stratification for IL-28b status; each cohort will consist of twenty (20) subjects, with 16 subjects assigned to active PSI-7977 and 4 subjects assigned to matching placebo in a 4:1 randomization.

Condition	Intervention	Phase
Hepatitis C	Drug: PSI-7977 100 mg Drug: PSI-7977 200 mg Drug: PSI-7977 400 mg Drug: Placebo Drug: Pegylated Interferon (PEG) Drug: Ribavirin (RBV)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

To assess the safety and tolerability of PSI-7977 for 28 days, administered in combination with Standard of Care (SOC; PEG-IFN and RBV), in treatment-naïve patients with HCV genotype 1 (GT-1). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the change in circulating HCV RNA in HCV GT-1, treatment-naïve patients after 28 days of dosing with PSI-7977 administered in combination with SOC. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	January 2010
Study Completion Date:	August 2011
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PSI-7977 100 mg Patients were randomized to receive PSI-7977 100 mg or matching placebo once daily with PEG+RBV	Drug: PSI-7977 100 mg PSI-7977 100 mg was administered once daily as one 100 mg tablet for 28 days, with PEG+RBV. Other Name: GS-7977 Drug: Placebo Placebo to match PSI-7977 was administered once daily as one 100 mg tablet for 28 days, with PEG+RBV. Drug: Pegylated Interferon (PEG) PEG was administered as an injectable solution for 28 days (according to prescribing instructions) with RBV, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks. Drug: Ribavirin (RBV) RBV was administered as a tablet for 28 days (according to prescribing instructions) with PEG, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks.
Experimental: PSI-7977 200 mg Patients were randomized to receive PSI-7977 200 mg or matching placebo once daily with PEG+RBV	Drug: PSI-7977 200 mg PSI-7977 200 mg was administered once daily as two 100 mg tablets for 28 days, with PEG+RBV. Other Name: GS-7977 Drug: Placebo Placebo to match PSI-7977 was administered once daily as one 100 mg tablet for 28 days, with PEG+RBV. Drug: Pegylated Interferon (PEG) PEG was administered as an injectable solution for 28 days (according to prescribing instructions) with RBV, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks. Drug: Ribavirin (RBV) RBV was administered as a tablet for 28 days (according to prescribing instructions) with PEG, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks.
Experimental: PSI-7977 400 mg Patients were randomized to receive PSI-7977 400 mg or matching placebo once daily with PEG+RBV	Drug: PSI-7977 400 mg PSI-7977 400 mg was administered once daily as four 100 mg tablets for 28 days, with PEG+RBV. Other Name: GS-7977 Drug: Placebo Placebo to match PSI-7977 was administered once daily as one 100 mg tablet for 28 days, with PEG+RBV. Drug: Pegylated Interferon (PEG) PEG was administered as an injectable solution for 28 days (according to prescribing instructions) with RBV, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks. Drug: Ribavirin (RBV) RBV was administered as a tablet for 28 days (according to prescribing instructions) with PEG, and with PSI-7977 or matching placebo. After 28 days of treatment, subjects continued to receive PEG+RBV for a total of 48 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

treatment naive males and females 18-65 years of age
HCV GT1 infection
negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

Hepatitis B or HIV Infection
pregnant or breast feeding females or male partners of pregnant females
previous interferon or ribavirin based therapy or investigational anti-HCV agent
history or evidence of medical condition associated with chronic liver disease other than HCV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054729

Locations

United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Texas
Alamo Medical Research Center
San Antonio, Texas, United States, 78215
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico, 00909

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Bob Hindes

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01054729 History of Changes
Other Study ID Numbers:	P7977-0221
Study First Received:	January 21, 2010
Last Updated:	May 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Chronic Hepatitis C infection Genotype 1
HCV
GT1
GT 1

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013