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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00874796
Other study ID # GS-US-227-0106
Secondary ID
Status Terminated
Phase Phase 2
First received April 2, 2009
Last updated January 3, 2014
Start date May 2009
Est. completion date July 2010

Study information

Verified date January 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of three treatment groups (80 subjects per treatment group) as follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily.

Following randomization, subjects will return within seven business days for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. During the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. Following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.


Recruitment information / eligibility

Status Terminated
Enrollment 307
Est. completion date July 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult subjects, ages 18-65

- Chronic HCV infection, defined as having documented HCV infection (antibody or RNA positivity) at least 6 months prior to Baseline (Day 1) with HCV viremia at screening

- Screening Knodell necroinflammatory score >= 3 based on liver biopsy evaluation (as determined by local pathologist) conducted anytime during the 45-day screening period

- ALT > the upper limit of the normal range (ULN) but < 10 X ULN at the screening visit

- Previously failed pegylated interferon-based HCV therapy in combination with ribavirin therapy, or is unable to tolerate or has contraindications to receiving interferon or ribavirin therapy

- BMI between 19 and 36 kg/m2 (inclusive)

- Creatinine clearance >= 70 mL/min

- absolute neutrophil count >= 1000/mm3

- Hemoglobin > 10 g/dL

- Have no clinical or laboratory evidence of hepatic decompensation

Exclusion Criteria:

- Decompensated liver disease

- Child-Pugh grade B or C cirrhosis

- Evidence of hepatocellular carcinoma

- Positive urine drug screen for cocaine or amphetamines

- Infection with HCV genotype 3

- Co-infection with hepatitis B virus or human immunodeficiency virus

- Pancreatitis

- Recent significant infection or symptoms of infection

- Autoimmune disorders

- Any history of seizure

- Is a public transportation operator (pilot of airplane or ship; air traffic controller; bus, train or subway driver) or operates heavy construction machinery

- Transplantation

- History of malignancy

- Current excessive alcohol ingestion, averaging > 3 drinks/day for females and > 4 drinks/day for males

- History of or current binge drinking

Study Design

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


Intervention

Drug:
GS-9450
Taken as one capsule by mouth once daily
Placebo
Taken as one placebo capsule (matching in appearance to GS-9450 capsules) by mouth once daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Puerto Rico,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Histologic response, defined as a >= 2-point decrease in Knodell necroinflammatory score with no concurrent worsening in the Knodell fibrosis score, at Week 24 . Week 24 on-treatment No
Secondary Change (absolute, percent) from baseline in the Knodell necroinflammatory score Baseline to Week 24 No
Secondary Change (absolute, percent) from pretreatment in alanine aminotransferase (ALT) levels Baseline to Week 24 No
Secondary Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities Up to 24 weeks plus 30 days following the last dose of study drug Yes
Secondary Change (absolute, percent) from baseline in cytokeratin-18 caspase cleavage fragment levels Baseline to Week 24 No
Secondary Change from baseline in hepatic collagen staining area as measured by morphometry of liver biopsy specimens Baseline to Week 24 No
Secondary Change from baseline in the percent of apoptotic cells Change from baseline in the percent of apoptotic cells (transferase deoxyuridine triphosphate [dUTP] nick end labeling [TUNEL] positive) as measured by TUNEL staining of liver biopsy specimens Baseline to Week 24 No
Secondary Change from baseline in percent of anti-M30 monoclonal antibody-positive hepatocytes Change from baseline in percent of anti-M30 monoclonal antibody-positive hepatocytes (for cytokeratin-18 neoantigen expression) as measured by immunohistochemical staining of liver biopsy specimens Baseline to Week 24 No
Secondary Change From Baseline in HCV RNA Baseline to to Week 24 No
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