Status:
COMPLETED
Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
PPD Development, LP
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GS...
Detailed Description
HCV infection is a major public health problem globally and a leading cause of chronic liver disease. New medications are needed that are better tolerated and offer a greater chance of achieving susta...
Eligibility Criteria
Inclusion
- Key
- Documented chronic genotype 1 or genotype 4 HCV infection
- Naïve to all HCV antiviral treatment(s)
- Agree to IL28B genotyping
- A body mass index \>18 kg/m2 but not exceeding 36 kg/m2
- Liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic. If no recent (\<36 months) liver biopsy is available, a study qualifying biopsy must be performed prior to Baseline (Day 1)
- All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment ends
- Otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening
- Key
Exclusion
- Positive test at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody
- History of any other clinically significant chronic liver disease
- History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease
- Positive results on urine screen for drugs of abuse test at Screening (unless used as medical treatment, e.g., with a prescription)
- History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation program)
- Screening ECG corrected QT interval value greater than 450 ms and/or clinically significant ECG findings
- A personal or family history of Torsade de Pointes findings
- Pregnant or nursing women
- Males with a female partner who is pregnant
- Abnormal hematological and biochemical parameters as specified in the protocol
- History of major organ transplantation with an existing functional graft
- Thyroid dysfunction not adequately controlled
- Subjects with a history of suicide attempt or hospitalization for depression in the past 5 years and/or any current (within 6 months) severe or poorly controlled psychiatric disorder
- History or current evidence of immunologic disorder; pulmonary, cardiac, or pulmonary disease; seizure disorder; cancer or history of malignancy that in the opinion of the investigator makes the subject unsuitable for the study
- Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to first dose administration
Key Trial Info
Start Date :
July 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01439373
Start Date
July 7 2011
End Date
December 5 2011
Last Update
December 11 2017
Active Locations (10)
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1
GSK Investigational Site
Anaheim, California, United States, 92801
2
GSK Investigational Site
Chula Vista, California, United States, 91911
3
GSK Investigational Site
Coronado, California, United States, 92118
4
GSK Investigational Site
La Mesa, California, United States, 91942