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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01435226
Other study ID # GS-US-248-0131
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2011
Last updated November 22, 2013
Start date September 2011
Est. completion date July 2013

Study information

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

Clinical Trial Summary

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date July 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years with chronic HCV infection

- Liver biopsy results = 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed

- Monoinfection with HCV genotype (GT) 1a or 1b

- HCV RNA = 104 IU/mL at screening

- Prior treatment and adherence with one course of pegylated interferon alfa and RBV

- The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.

- Body mass index (BMI) 18-40 kg/m2 inclusive

- Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)

= 450 msec for males and = 470 msec for females.

- Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

Exclusion Criteria:

- Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up

- History of significant cardiac disease

- Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (TSH).

- Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.

- Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for = 6 months is permitted.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
GS-5885
Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD
GS-9451
Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD
tegobuvir
tegobuvir 30 mg BID
placebo to match tegobuvir
tegobuvir placebo BID
placebo to match RBV
Ribovirin placebo BID
Ribavirin
Ribavirin (Copegus®) BID (1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing = 75 kg) divided BID

Locations

Country Name City State
Germany Charite - Universitatsmedizin Berlin Campus Virchow-Klinikum Berlin
Germany Leber- and Studienzentrum am Checkpoint Berlin
Germany Universitätsklinikum Bonn Bonn
Germany Center for HIV and Hepatogastroenterology Düsseldorf
Germany Klinikum der Johann Wolfgang Goethe Universitaet Frankfurt
Germany Medizinische Universitatsklinik Freiburg
Germany Universitatsklinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Klinikum der Universität Heidelberg Heidelberg
Germany Gastroenterologisch-Hepatologisches Zentrum Kiel Kiel
Germany Universitätsklinikum Leipzig Leipzig
Germany Johannes Gutenberg University Hospital Mainz
Germany Klinikum Innenstadt der LMU Munchen Muenchen
Germany Universitätsklinikum Würzburg - Med Klinik und Poliklinik Würzburg
United States Advanced Clinical Research Institute, LLC Anaheim California
United States Mercy Medical Center Baltimore Maryland
United States California Liver Institute Beverly Hills California
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States SCTI Research Foundation Liver Center Coronado California
United States Southwest Infectious Disease Clinical Research, Inc Dallas Texas
United States Infectious Disease Specialists of Atlanta Decatur Georgia
United States Avail Clinical Research, LLC DeLand Florida
United States University of Texas Medical Branch Galveston Texas
United States Gastro One Germantown Tennessee
United States The University of Texas Health Sciences Center at Houston Houston Texas
United States Therapeutic Concepts, PA Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States University of California, San Diego La Jolla California
United States Lightsource Medical Los Angeles California
United States Johns Hopkins University Lutherville Maryland
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States University of Miami, Center for Liver Diseases Miami Florida
United States Mount Sinai School of Medicine New York New York
United States Weill Medical College of Cornell Univeristy New York New York
United States Bon Secours St. Mary's Hospital of Richmond, Inc. Newport News Virginia
United States Digestive and Liver Disease Specialists Norfolk Virginia
United States Henry Ford Health System Novi Michigan
United States University of Pennsylvania Philadelphia Pennsylvania
United States University Gastroenterology Providence Rhode Island
United States University of Utah Salt Lake City Utah
United States Alamo Medical Research, Ltd. San Antonio Texas
United States Kaiser Permanente San Diego California
United States Medical Associates Research Group, Inc. San Diego California
United States California Pacific Medical Center San Francisco California
United States San Jose Gastroenterology San Jose California
United States Virginia Mason Medical Center Seattle Washington
United States University of Arizona Tucson Arizona
United States Whitman Walker Clinic Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
24 weeks Yes
Primary Antiviral Activity To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA < lower limit of quantitation [LLoQ] 24 weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection 24 weeks No
Secondary Viral Dynamics To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. 10 days No
Secondary Composite (or Profile) of Pharmacokinetics Composite (or Profile) of Pharmacokinetics To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, ?z, AUCtau and T ½ predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose No
Secondary Antiviral Efficacy To evaluate the antiviral efficacy (as defined by SVR) of adding pegylated interferon alfa-2a (PEG) and RBV (Arm 2 only) for 24-48 weeks to the original treatment regimen in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy 24-48 weeks No
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