Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:12/13/2017
Start Date:July 7, 2011
End Date:December 5, 2011

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Double-Blind, Randomized, Placebo-Controlled Study to Assess Safety, Efficacy, and Pharmacokinetics (PK) of GSK2336805 in Combination With Peginterferon and Ribavirin in Treatment-naive Chronic Hepatitis C Subjects With Hepatitis C Virus Genotypes 1 or 4

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 GSK2336805 alone and in combination with peginterferon alfa 2a and
ribavirin in subjects with chronic hepatitis C (CHC).

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 sustained viral clearance compared to currently available therapy. GSK2336805 is a
HCV NS5A inhibitor being developed for the treatment of subjects with CHC. This Phase II,
double blind, randomized, placebo-controlled study will assess the safety, antiviral
activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa
2a and ribavirin in subjects with CHC. Subjects will be randomly allocated on a 2:1 basis to
GSK2336805 or matching placebo and will be stratified by IL28B status and HCV viral genotype
(genotype 1 or 4). The study consists of 2 parts. In Part 1, GSK2336805 or matching placebo
will be given as single-dose monotherapy (Day 1). In Part 2, GSK2336805 or matching placebo
will be co-administered with peginterferon alfa-2a and ribavirin through 4 weeks of treatment
(Days 2 to 28). After completion of Part 2, GSK2336805/matching placebo will be discontinued
and subjects will be offered continued standard-of-care anti-HCV therapy.

Key Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
10
sites
Anaheim, California 92807
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Chula Vista, California 91911
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Chula Vista, CA
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Coronado, California 92118
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Coronado, CA
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Houston, Texas 77030
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Houston, TX
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La Mesa, California 91942
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La Mesa, CA
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Miramar, Florida 33027
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Miramar, FL
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Oceanside, California 92056
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Oceanside, CA
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San Juan, 00927
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San Juan,
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Tulsa, Oklahoma 74105
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Tulsa, OK
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