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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00244751 |
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C |
Drug: GI262570 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Multi-Center, Phase II Parallel Dose-Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects With Hepatic Fibrosis Who Have Failed Prior Antiviral Therapy |
Enrollment: | 225 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Male or female; a female is eligible to enter and participate in this study if she is of:
child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following:
Exclusion criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Hemoglobin (<12.5 g/dL for men)(<12.0 g/dL for women)
Absolute Neutrophil Count (ANC) (<1.0 x 10^9/L) Platelets (<130X/10^9/L)
Serum creatinine (>1.5mg/dL (≥130mmol/L)) Calculated creatinine clearance as calculated by Cockcroft and Gault (<60mL/min)
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | FBX104114 |
Study First Received: | October 25, 2005 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00244751 History of Changes |
Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
Hepatitis C liver fibrosis |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatic Fibrosis Hepatitis, Chronic |
Fibrosis Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |